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[18F]Fluorthanatrace - Positron Emission Tomography (FTT-PET) and ctDNA to Predict Response to PARP Inhibitor Therapy in Metastatic Prostate Cancer (mPC)

19. juli 2026 oppdatert av: Washington University School of Medicine

Integration of FTT-PET and ctDNA to Predict Response to PARP Inhibitor Therapy in Metastatic Prostate Cancer (mPC)

This multicenter center, open-label, baseline-controlled diagnostic imaging study designed to assess the use of Fluorthanatrace-Positron Emission tomography (FTT-PET) as a PARP inhibitor (PARPi) therapy predictive imaging biomarker and the use of EnhanceAR-Seq (ctDNA) in predicting response to therapy and to identify genomic alterations associated with resistance. Furthermore, to correlate changes in ctDNA and imaging (FTT-PET and standard of care imaging) to understand the dynamics of tumor response.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

75

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Forente stater
    • Missouri
      • St Louis, Missouri, Forente stater, 63110
        • Washington University School of Medicine
        • Ta kontakt med:
        • Underetterforsker:
          • Richard Laforest, PhD
        • Underetterforsker:
          • Kooresh I Shoghi, PhD
        • Underetterforsker:
          • Christopher A Maher, PhD
        • Underetterforsker:
          • Cody Weimholt, MD
        • Underetterforsker:
          • Melissa A Reimers, MD
        • Underetterforsker:
          • Yu Tao, MD
        • Underetterforsker:
          • Buck Rogers, PhD
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forente stater, 19104
        • University of Pennsylvania Abramson Cancer Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • Nei Taunk, MD
    • Texas
      • Houston, Texas, Forente stater, 77030
        • University of Texas MD Anderson Cancer Center
        • Ta kontakt med:
          • Lilie Lin, MD
          • Telefonnummer: 713-792-2121
        • Hovedetterforsker:
          • Lilie Lin, MD
        • Underetterforsker:
          • Franklin Wong, MD
        • Underetterforsker:
          • Patrick G Pilie, MD

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  • Adult male patients 18 years of age or older
  • mCRPC with confirmed germline or somatic HRR (such as ATM, ATR, BRCA1, BRCA2, CDK12, CHEK2, FANCA, MLH1, MRE11A, NBN, PALB2, or RAD51C for Talazoparib/enzalutamide and ATMm, BRCA1m, BRCA2m, BARD1m, BRIP1m, CDK12m, CHEK1m, CHEK2m, FANCLm, PALB2m, RAD51Bm, RAD51Cm, RAD51Dm, RAD54Lm; gBRCA1m, gBRCA2m; ATMm, BRCA1m, BRCA2m for Olaparib +/- abiraterone) mutations who are scheduled for SOC PARPi therapy.
  • Lesion size of at least 1.0 cm in longest dimension by imaging. If non-measurable, lesion needs to be clearly detected on other imaging studies such as bone scintigraphy, FDG-PET, PSMA-PET or MRI.
  • On continuous androgen deprivation therapy (ADT) with appropriately suppressed castrate testosterone levels of < 50 ng/dL, or prior bilateral orchiectomy.
  • Serum PSA of 2 ng/mL or greater.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
  • Able to give informed consent

Exclusion Criteria:

  • Receipt of prior PARP inhibitor therapy in any disease setting.
  • Patients with other invasive malignancies, with the exception of non-melanoma skin cancer, who had (or have) any evidence of the other cancer that is active at the time of enrollment.
  • Unable to tolerate approximately 30 min (total time) of PET/CT imaging.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Diagnostisk
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: FTT-PET/CT

Participants will undergo two FluorThanatrace (FTT) Positron Emission Tomography/Computed tomography (PET/CT) scans; one at baseline prior to starting standard of care (SOC) PARP inhibitor (PARPi) therapy and one two weeks after initiation of PARPi therapy. Each cycle of PARPi therapy is 28 days.

Blood samples for EnhanceAR-Seq ctDNA analysis will be collected from participants at baseline prior to therapy, post cycle 1,12 weeks after PARPi initiation, and at time of disease progression.

Eight participants will undergo an additional FTT-PET/CT prior to initiation of PARPi therapy.
Legemiddel: 1-(4-(2-Fluoroethoxy)phenyl)-8,9-dihiydro-2,7,9a-triazabenzo[cd]azulen-6(7H)-one
[18F]fluorthanatrace (FTT) is a positron emitting radiopharmaceutical that is administered as an intravenous (IV) solution via injection at a prescribed dose of 10mCi. A lesser dose may be injected if complete imaging data could be generated.
Andre navn:
  • [18F]FluorThanatrace
  • [18F]FTT
  • FTT
Enhet: FTT-PET/CT
A small intravenous (IV) catheter will be placed in the arm vein according to site's standard practice to allow injection of FTT. Approximately sixty minutes following administration of approximately 10 mCi of the radiotracer FTT, patients will undergo standard body PET/CT imaging.
Diagnostisk test: EnhanceAR-Seq
Patients will undergo approximately 30 mL of peripheral blood sample collection to be used for analysis. For each sample, EnhanceAR-Seq will be performed on each of these samples, with somatic genomic alteration calling performed in plasma cell-free DNA with removal of background non-tumor variants using matched plasma-depleted whole blood germline samples.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Prediction performance of FTT-PET as measured by concordance index (C-index)
Tidsramme: At baseline prior to PARPi therapy and post cycle 1 (estimated total time 28 days)
Prediction performance of FTT-PET in predicting participant response to PARPi therapy will be assessed by concordance index (C-index). The C-index is mathematically calculated as the number of concordant pairs divided by the number of comparable pairs. A C-index of 1 indicates perfect ranking, values close to 0.5 indicate random prediction, and values between 0.5 and 1 suggest some predictive ability (a value below 0.5 can be reversed by switching the response's 0 and 1 labels).
At baseline prior to PARPi therapy and post cycle 1 (estimated total time 28 days)
Prediction performance of FTT-PET as measured by area under the receiver operating characteristic (ROC) curve
Tidsramme: At baseline prior to PARPi therapy and post cycle 1 (estimated total time 28 days)
Prediction performance of FTT-PET in predicting participant response to PARPi therapy will be assessed by the area under the ROC curve. The ROC curve is a graphical plot that illustrates the performance of a model at various threshold settings and the area under the curve (AUC) is a single scalar value between 0 and 1 that summarizes the model performance. A higher AUC value indicates better performance.
At baseline prior to PARPi therapy and post cycle 1 (estimated total time 28 days)
Prediction performance of EnhanceAR-Seq ctDNAas measured by concordance index (C-index)
Tidsramme: At baseline prior to PARPi therapy, post cycle 1 (cycle is an estimated 28 days), 12 weeks after start of PARPi therapy, and at progression if applicable (estimated total time 6 months)
Prediction performance of EnhanceAR-Seq ctDNA analysis in predicting participant response to PARPi therapy will be assessed by concordance index (C-index). The C-index is calculated as the number of concordant pairs divided by the number of comparable pairs. A C-index of 1 indicates perfect ranking, values close to 0.5 indicate random prediction, and values between 0.5 and 1 suggest some predictive ability (a value below 0.5 can be reversed by switching the response's 0 and 1 labels).
At baseline prior to PARPi therapy, post cycle 1 (cycle is an estimated 28 days), 12 weeks after start of PARPi therapy, and at progression if applicable (estimated total time 6 months)
Prediction performance of EnhanceAR-Seq ctDNA as measured by area under the receiver operating characteristic (ROC) curve
Tidsramme: At baseline prior to PARPi therapy, post cycle 1 (cycle is an estimated 28 days), 12 weeks after start of PARPi therapy, and at progression if applicable (estimated total time 6 months)
Prediction performance of EnhanceAR-Seq ctDNA analysis in predicting participant response to PARPi therapy will be assessed by the area under the ROC curve. The ROC curve is a graphical plot that illustrates the performance of a model at various threshold settings and the area under the curve (AUC) is a single scalar value between 0 and 1 that summarizes the model performance. A higher AUC value indicates better performance.
At baseline prior to PARPi therapy, post cycle 1 (cycle is an estimated 28 days), 12 weeks after start of PARPi therapy, and at progression if applicable (estimated total time 6 months)
Prediction performance of FTT-PET and EnhanceAR-Seq ctDNA collectively as measured by concordance index (C-index)
Tidsramme: At baseline prior to PARPi therapy, post cycle 1 (cycle is an estimated 28 days), and at progression if applicable (estimated total time 6 months)
Prediction performance of FTT-PET and EnhanceAR-Seq ctDNA analysis collectively in predicting participant response to PARPi therapy will be assessed by concordance index (C-index). The C-index is calculated as the number of concordant pairs divided by the number of comparable pairs. A C-index of 1 indicates perfect ranking, values close to 0.5 indicate random prediction, and values between 0.5 and 1 suggest some predictive ability (a value below 0.5 can be reversed by switching the response's 0 and 1 labels).
At baseline prior to PARPi therapy, post cycle 1 (cycle is an estimated 28 days), and at progression if applicable (estimated total time 6 months)
Prediction performance of FTT-PET and EnhanceAR-Seq ctDNA collectively as measured by area under the receiver operating characteristic (ROC) curve
Tidsramme: At baseline prior to PARPi therapy, post cycle 1 (cycle is an estimated 28 days), and at progression if applicable (estimated total time 6 months)
Prediction performance of FTT-PET and EnhanceAR-Seq ctDNA analysis collectively in predicting participant response to PARPi therapy will be assessed by the area under the ROC curve. The ROC curve is a graphical plot that illustrates the performance of a model at various threshold settings and the area under the curve (AUC) is a single scalar value between 0 and 1 that summarizes model performance. A higher AUC value indicates better performance.
At baseline prior to PARPi therapy, post cycle 1 (cycle is an estimated 28 days), and at progression if applicable (estimated total time 6 months)
Sensitivity of EnhanceAR-Seq ctDNA in identifying mPC patients who respond to PARPi therapy
Tidsramme: At baseline prior to PARPi therapy, post cycle 1 (cycle is an estimated 28 days), 12 weeks after start of PARPi therapy, and at progression if applicable (estimated total time 6 months)
Sensitivity is calculated as the proportion of true positives divided by the sum of true positives and false negatives. The area under the Receiver Operating Characteristic (ROC) curve will be calculated to identify the optimal cutpoint on the ROC corresponding to the maximized Youden index to evaluate sensitivity. The ROC curve is a graphical plot that illustrates the performance of a model at various threshold settings and the area under the curve (AUC) is a single scalar value between 0 and 1 that summarizes model performance. A higher AUC value indicates better performance.
At baseline prior to PARPi therapy, post cycle 1 (cycle is an estimated 28 days), 12 weeks after start of PARPi therapy, and at progression if applicable (estimated total time 6 months)
Specificity of EnhanceAR-Seq ctDNA in identifying mPC patients who respond to PARPi therapy
Tidsramme: At baseline prior to PARPi therapy, post cycle 1 (cycle is an estimated 28 days), 12 weeks after start of PARPi therapy, and at progression if applicable (estimated total time 6 months)
Specificity is calculated as the proportion of true negatives divided by the sum of true negatives and false positives. The area under the Receiver Operating Characteristic (ROC) curve will be calculated to identify the optimal cutpoint on the ROC corresponding to the maximized Youden index to evaluate specificity. The ROC curve is a graphical plot that illustrates the performance of a model at various threshold settings and the area under the curve (AUC) is a single scalar value between 0 and 1 that summarizes the performance of model. A higher AUC value indicates better performance.
At baseline prior to PARPi therapy, post cycle 1 (cycle is an estimated 28 days), 12 weeks after start of PARPi therapy, and at progression if applicable (estimated total time 6 months)
Positive predictive value (PPV) of EnhanceAR-Seq ctDNA in identifying mPC patients who respond to PARPi therapy
Tidsramme: At baseline prior to PARPi therapy, post cycle 1 (cycle is an estimated 28 days), 12 weeks after start of PARPi therapy, and at progression if applicable (estimated total time 6 months)
PPV is calculated as the number of true positives divided by the sum of the number of true positives and number of false positives. The area under the Receiver Operating Characteristic (ROC) curve will be calculated to identify the optimal cutpoint on the ROC corresponding to the maximized Youden index to evaluate PPV. The ROC curve is a graphical plot that illustrates the performance of a model at various threshold settings and the area under the curve (AUC) is a single scalar value between 0 and 1 that summarizes model performance. A higher AUC value indicates better performance.
At baseline prior to PARPi therapy, post cycle 1 (cycle is an estimated 28 days), 12 weeks after start of PARPi therapy, and at progression if applicable (estimated total time 6 months)
Negative predictive value (NPV) of EnhanceAR-Seq ctDNA in identifying mPC patients who respond to PARPi therapy
Tidsramme: At baseline prior to PARPi therapy, post cycle 1 (cycle is an estimated 28 days), 12 weeks after start of PARPi therapy, and at progression if applicable (estimated total time 6 months)
NPV is calculated as the number of true negatives divided by the sum of the number of true negatives and number of false negatives. The area under the Receiver Operating Characteristic (ROC) curve will be calculated to identify the optimal cutpoint on the ROC corresponding to the maximized Youden index to evaluate NPV. The ROC curve is a graphical plot that illustrates the performance of a model at various threshold settings and the area under the curve (AUC) is a single scalar value between 0 and 1 that summarizes model performance. A higher AUC value indicates better performance.
At baseline prior to PARPi therapy, post cycle 1 (cycle is an estimated 28 days), 12 weeks after start of PARPi therapy, and at progression if applicable (estimated total time 6 months)
Predictive performance improvement as measured by change in concordance index of FTT-PET and EnhanceAR-seq ctDNA compared to only FTT-PET or only EnhanceAR-seq ctDNA
Tidsramme: At baseline prior to PARPi therapy, post cycle 1 (cycle is an estimated 28 days), 12 weeks after start of PARPi therapy, and at progression if applicable (estimated total time 6 months)
Prediction performance of FTT-PET and EnhanceAR-seq ctDNA in predicting participant response to PARPi therapy will be assessed by the concordance index (C-index). The C-index is calculated as the number of concordant pairs divided by the number of comparable pairs. A C-index of 1 indicates perfect ranking, values close to 0.5 indicate random prediction, and values between 0.5 and 1 suggest some predictive ability prediction (a value below 0.5 can be reversed by switching the response's 0 and 1 labels).
At baseline prior to PARPi therapy, post cycle 1 (cycle is an estimated 28 days), 12 weeks after start of PARPi therapy, and at progression if applicable (estimated total time 6 months)
Predictive performance improvement as measured by area under the receiver operating characteristic (ROC) curve of FTT-PET and EnhanceAR-seq ctDNA compared to only FTT-PET or only EnhanceAR-seq ctDNA
Tidsramme: At baseline prior to PARPi therapy, post cycle 1 (cycle is an estimated 28 days), 12 weeks after start of PARPi therapy, and at progression if applicable (estimated total time 6 months)
Prediction performance of FTT-PET and EnhanceAR-seq ctDNA in predicting participant response to PARPi therapy will be assessed by the area under the ROC curve. The ROC curve is a graphical plot that illustrates the performance of a model at various threshold settings and the area under the curve (AUC) is a single scalar value between 0 and 1 that summarizes model performance. A higher AUC value indicates better performance.
At baseline prior to PARPi therapy, post cycle 1 (cycle is an estimated 28 days), 12 weeks after start of PARPi therapy, and at progression if applicable (estimated total time 6 months)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Test-Retest Only: Lin's intra-class correlation coefficient of FTT-PET imaging
Tidsramme: At baseline prior to PARPi therapy, at retest scan 1-14 days after baseline scan, and post-cycle 1 (estimated total time 28 days)
Defined as concordance between a new test or measurement (Y) and a gold standard test or measurement (X). This statistic quantifies the agreement between these two measures of the same variable. Ranges from -1 to 1, with perfect agreement at 1.
At baseline prior to PARPi therapy, at retest scan 1-14 days after baseline scan, and post-cycle 1 (estimated total time 28 days)
Correlation between FTT-PET imaging and tumor mutation burden (TMBddr) as assessed by Spearman or Pearson correlation coefficient
Tidsramme: At baseline and post cycle 1 (estimated total time 28 days)

TMBddr is the number of genetic mutation in tumor cells that can affect patient response and will be assessed through EnhanceAR-Seq ctDNA.

Spearman's correlation coefficient evaluates the association and the association's direction between two ranked continuous variables. Spearman's correlation coefficient ranges from -1 to 1, with a negative number indicating a negative relationship between variables and a positive number indicating a positive relationship between variables. Values closer to zero indicate a weak relationship.

Pearson's correlation coefficient is a measure that evaluates the association between two continuous variables with the assumption that the variables have a linear relationship. Pearson's correlation coefficient ranges from -1 to 1, with a negative number indicating a negative relationship between variables and a positive number indicating a positive relationship between variables. Values closer to zero indicate a weak relationship.
At baseline and post cycle 1 (estimated total time 28 days)
Correlation between FTT-PET imaging and variant allele frequency (VAF) as assessed by Spearman or Pearson correlation coefficient
Tidsramme: At baseline and post cycle 1 (estimated total time 28 days)

VAF represents the fraction of variant sequencing reads within a genetic locus and will be assessed through EnhanceAR-Seq ctDNA.

Spearman's correlation coefficient evaluates the association and the association's direction between two ranked continuous variables. Spearman's correlation coefficient ranges from -1 to 1, with a negative number indicating a negative relationship between variables and a positive number indicating a positive relationship between variables. Values closer to zero indicate a weak relationship.

Pearson's correlation coefficient is a measure that evaluates the association between two continuous variables with the assumption that the variables have a linear relationship. Pearson's correlation coefficient ranges from -1 to 1, with a negative number indicating a negative relationship between variables and a positive number indicating a positive relationship between variables. Values closer to zero indicate a weak relationship.
At baseline and post cycle 1 (estimated total time 28 days)
Correlation between FTT-PET imaging and dynamic changes in ctDNA levels as assessed by Spearman or Pearson correlation coefficient
Tidsramme: At baseline and post cycle 1 (estimated total time 28 days)

Dynamic changes in ctDNA refer to measurable changes in circulating tumor DNA in patient's blood over time and will be assessed through EnhanceAR-Seq ctDNA.

Spearman's correlation coefficient evaluates the association and the association's direction between two ranked continuous variables. Spearman's correlation coefficient ranges from -1 to 1, with a negative number indicating a negative relationship between variables and a positive number indicating a positive relationship between variables. Values closer to zero indicate a weak relationship.

Pearson's correlation coefficient is a measure that evaluates the association between two continuous variables with the assumption that the variables have a linear relationship. Pearson's correlation coefficient ranges from -1 to 1, with a negative number indicating a negative relationship between variables and a positive number indicating a positive relationship between variables. Values closer to zero indicate a weak relationship.
At baseline and post cycle 1 (estimated total time 28 days)
Correlation between FTT-PET imaging and prostate-specific antigen (PSA) levels as assessed by Spearman or Pearson correlation coefficient
Tidsramme: At baseline and post cycle 1 (estimated total time 28 days)

Changes PSA levels in the blood over time will be assessed through EnhanceAR-Seq ctDNA.

Spearman's correlation coefficient evaluates the association and the association's direction between two ranked continuous variables. Spearman's correlation coefficient ranges from -1 to 1, with a negative number indicating a negative relationship between variables and a positive number indicating a positive relationship between variables. Values closer to zero indicate a weak relationship.

Pearson's correlation coefficient is a measure that evaluates the association between two continuous variables with the assumption that the variables have a linear relationship. Pearson's correlation coefficient ranges from -1 to 1, with a negative number indicating a negative relationship between variables and a positive number indicating a positive relationship between variables. Values closer to zero indicate a weak relationship.
At baseline and post cycle 1 (estimated total time 28 days)
Correlation between FTT-PET imaging and tumor mutation burden (TMBddr) as assessed by Kappa agreement coefficient
Tidsramme: At baseline and post cycle 1 (estimated total time 28 days)

TMBddr is the number of genetic mutation in tumor cells that can affect patient response and will be assessed through EnhanceAR-Seq ctDNA.

The Kappa agreement measure is calculated to evaluated inter-rater reliability. Kappa coefficient scores range from -1 to 1 with scores closer to 0 indicate poor or little agreement and scores of 1 or -1 indicating perfect agreement.
At baseline and post cycle 1 (estimated total time 28 days)
Correlation between FTT-PET imaging and variant allele frequency (VAF) as assessed by Kappa agreement coefficient
Tidsramme: At baseline and post cycle 1 (estimated total time 28 days)

VAF represents the fraction of variant sequencing reads within a genetic locus and will be assessed through EnhanceAR-Seq ctDNA.

The Kappa agreement measure is calculated to evaluate inter-rater reliability. Kappa coefficient scores range from -1 to 1, with scores closer to 0 indicating poor or little agreement and scores of 1 or -1 indicating perfect agreement.
At baseline and post cycle 1 (estimated total time 28 days)
Correlation between FTT-PET imaging and dynamic changes in ctDNA level as assessed by Kappa agreement coefficient
Tidsramme: At baseline and post cycle 1 (estimated total time 28 days)

Dynamic changes in ctDNA refer to measurable changes in circulating tumor DNA in patient's blood over time and will be assessed through EnhanceAR-Seq ctDNA.

The Kappa agreement measure is calculated to evaluated inter-rater reliability. Kappa coefficient scores range from -1 to 1, with scores closer to 0 indicating poor or little agreement and scores of 1 or -1 indicating perfect agreement.
At baseline and post cycle 1 (estimated total time 28 days)
Correlation between FTT-PET imaging and prostate-specific antigen (PSA) as assessed by Kappa agreement coefficient
Tidsramme: At baseline and post cycle 1 (estimated total time 28 days)

Changes PSA levels in the blood over time will be assessed through EnhanceAR-Seq ctDNA.

The Kappa agreement measure is calculated to evaluate inter-rater reliability. Kappa coefficient scores range from -1 to 1, with scores closer to 0 indicating poor or little agreement and scores of 1 or -1 indicating perfect agreement.
At baseline and post cycle 1 (estimated total time 28 days)
Association of FTT-PET and EnhanceAR-Seq metrics with patient response based on relative risk
Tidsramme: From enrollment to time of progression (estimated total time 6 months)
Relative risk is a measure of the ratio of the risk of a certain event in an exposed group compared to the risk of the same event in a control group. A relative risk of 1.0 indicates no difference in risk between the groups, greater than 1.0 indicates increased risk in the exposed group, and less than 1.0 indicates decreased risk in the exposed group.
From enrollment to time of progression (estimated total time 6 months)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Washington University School of Medicine

Samarbeidspartnere

National Cancer Institute (NCI)

Etterforskere

  • Hovedetterforsker: Farrokh Dehdashti, MD, Washington University School of Medicine

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. september 2026

Primær fullføring (Antatt)

31. mars 2032

Studiet fullført (Antatt)

31. mars 2032

Datoer for studieregistrering

Først innsendt

19. juli 2026

Først innsendt som oppfylte QC-kriteriene

19. juli 2026

Først lagt ut (Faktiske)

23. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

23. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

19. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 202605165

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

De-identified individual participant data collected during the trial, metadata collection, and supporting files will be shared via National Cancer Institute (NCI) repositories. Deidentified clinical images will be shared through The Cancer Imaging Archive (TCIA) and the Imaging Data Commons (IDC) of NCI. Genomic data will be shared via the NCI Genomic Data Commons (GDC).

IPD-delingstidsramme

Data will be available as soon as possible, but no later than the time of publication or the end of the funding period, whichever comes first. The duration of preservation and sharing of the data will be determined based on timelines established by respective NCI repositories.

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • ICF

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Ja

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere