Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

FLT PET/CT til måling af respons hos patienter med tidligere ubehandlet akut myeloid leukæmi

22. september 2026 opdateret af: National Cancer Institute (NCI)

Tidlig vurdering af behandlingsrespons i AML ved hjælp af FLT PET/CT-billeddannelse

This phase II trial studies fluorothymidine F 18 (FLT) positron emission tomography (PET)/computed tomography (CT) in measuring response in patients with previously untreated acute myeloid leukemia. FLT is a radioactive substance that may "light up" where cancer is in the body. FLT is injected into the blood and builds up in cells that are dividing, including cancer cells. Diagnostic procedures, such as PET/CT, may help measure a patient's response to earlier treatment.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

PRIMARY OBJECTIVES:

I. To evaluate the negative predictive value (NPV) of post-treatment FLT PET/CT imaging for complete remission (CR) in patients receiving induction chemotherapy for acute myeloid leukemia (AML).

SECONDARY OBJECTIVES:

I. To evaluate the positive predictive value (PPV) of post-treatment FLT PET/CT imaging for complete remission.

II. To estimate the sensitivity and specificity of post-treatment FLT PET/CT imaging for detecting complete remission.

III. To correlate FLT PET/CT imaging with biologic correlates (minimal residual disease [MRD] assessment) IV. To correlate FLT PET/CT imaging with relapse-free survival and overall survival.

EXPLORATORY OBJECTIVES:

III. To evaluate pre-treatment FLT PET/CT imaging as a predictor of complete remission.

IV. To evaluate the change between pre-treatment and post-treatment FLT PET/CT imaging as a predictor of complete remission.

OUTLINE:

Patients receive anthracycline intravenously (IV) on days 1-3 and cytarabine IV on days 1-7 for up to 2 courses. Patients then undergo FLT PET/CT within 3 days before or after the nadir bone marrow biopsy (between days 10-17 after initiation of first induction cycle and prior to reinduction). Patients may undergo an optional FLT PET/CT prior to induction chemotherapy if it does not interfere with commencement of treatment. Patients also undergo bone marrow biopsy and aspiration and blood sample collection during screening and on the trial.

After completion of study, patients are followed up at day 28-35, and then up to 1 year beyond the end of study accrual period.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

87

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Minnesota
      • Rochester, Minnesota, Forenede Stater, 55905
        • Mayo Clinic in Rochester
    • Missouri
      • St Louis, Missouri, Forenede Stater, 63110
        • Washington University School of Medicine
    • New York
      • New York, New York, Forenede Stater, 10029
        • Mount Sinai Hospital
    • North Carolina
      • Chapel Hill, North Carolina, Forenede Stater, 27599
        • UNC Lineberger Comprehensive Cancer Center
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73104
        • University of Oklahoma Health Sciences Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19111
        • Fox Chase Cancer Center
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • University of Pennsylvania/Abramson Cancer Center
    • Tennessee
      • Nashville, Tennessee, Forenede Stater, 37232
        • Vanderbilt University/Ingram Cancer Center
    • Texas
      • Dallas, Texas, Forenede Stater, 75390
        • UT Southwestern/Simmons Cancer Center-Dallas
    • Utah
      • Salt Lake City, Utah, Forenede Stater, 84112
        • Huntsman Cancer Institute/University of Utah
    • Wisconsin
      • Madison, Wisconsin, Forenede Stater, 53792
        • University of Wisconsin Carbone Cancer Center - University Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Age ≥ 18 years
  • Patients must have previously untreated AML and be candidates for intensive induction chemotherapy; patients are allowed to have had prior hydroxyurea
  • Patients must not have acute promyelocytic leukemia (APL) and must not have evidence of t(15;17)(q22;q21)
  • Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-3 (restricted to ECOG performance status [PS] 0-2 if age > 70 years)
  • Patients must have left ventricular ejection fraction (LVEF) > 45% or within institutional normal limits
  • Patients must be able to lie still for a 1.5 hour PET scan
  • Patient must NOT have a history of allergic reaction attributable to compounds of similar chemical or biologic composition to 18F-fluorothymidine
  • Patient must NOT weigh more than the maximum weight limit for the PET/CT table for the scanner(s) to be used at each center
  • The patient is participating in the trial at an institution which has agreed to perform the imaging research studies, completed the ECOG-American College of Radiology Imaging Network (ACRIN) defined scanner qualification procedures and received ECOG-ACRIN approval as outlined
  • Women must not be pregnant or breast-feeding; all females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Diagnostisk
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Diagnostic (anthracycline, cytarabine, FLT PET/CT)

Patients receive anthracycline IV on days 1-3 and cytarabine IV on days 1-7 for up to 2 courses. Patients then undergo FLT PET/CT within 3 days before or after the nadir bone marrow biopsy (between days 10-17 after initiation of first induction cycle and prior to reinduction). Patients may undergo an optional FLT PET/CT prior to induction chemotherapy if it does not interfere with commencement of treatment. Patients also undergo bone marrow biopsy and aspiration and blood sample collection during screening and on the trial.
Andet: Laboratory Biomarker Analysis

Correlative studies

Medicin: Cytarabine

Given IV

Andre navne:
  • Β-Cytosin arabinosid
  • 1-β-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinon
  • 1-β-D-Arabinofuranosylcytosin
  • 1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinon
  • 1-Beta-D-arabinofuranosylcytosin
  • 1β-D-Arabinofuranosylcytosin
  • 2(1H)-pyrimidinon, 4-amino-1-beta-D-arabinofuranosyl-
  • 2(1H)-pyrimidinon, 4-amino-1P-D-arabinofuranosyl-
  • Alexan
  • Ara-C
  • ARA-celle
  • Arabine
  • Arabinofuranosylcytosin
  • Arabinosylcytosin
  • Aracytidin
  • Aracytin
  • Beta-Cytosin Arabinoside
  • CHX-3311
  • Cytarabinum
  • Cytarbel
  • Cytosar
  • Cytosin Arabinoside
  • Cytosin-β-arabinosid
  • Cytosin-beta-arabinosid
  • Erpalfa
  • Starasid
  • Tarabin PFS
  • U 19920
  • U-19920
  • Udicil
  • WR-28453
Procedure: Biospecimen Collection

Undergo blood sample collection

Andre navne:
  • Biologisk prøvesamling
  • Bioprøve indsamlet
  • Prøvesamling
  • Prøvekollektion
Procedure: Bone Marrow Aspiration

Undergo bone marrow biopsy and aspiration

Procedure: Bone Marrow Biopsy

Undergo bone marrow biopsy and aspiration

Andre navne:
  • Biopsi af knoglemarv
  • Biopsi, knoglemarv
Medicin: Chemotherapy

Given anthracycline IV

Andre navne:
  • Chemo
  • Kemoterapi (NOS)
  • Kemoterapi, Kræft, Generelt
Procedure: Computed Tomography

Undergo FLT PET/CT

Andre navne:
  • CT
  • KAT
  • CAT-scanning
  • Beregnet aksial tomografi
  • Computerstyret aksial tomografi
  • Computerstyret tomografi
  • CT-scanning
  • tomografi
  • Computerstyret aksial tomografi (procedure)
  • Computerstyret tomografi (CT) scanning
  • Diagnostisk CAT -scanning
  • Diagnostic CAT Scan Service Type
Andet: Fluorothymidine F-18

Undergo FLT PET/CT

Andre navne:
  • 18F-FLT
  • 3'-deoxy-3'-[18F]fluorthymidin
  • 3'-Deoxy-3'-(18F) Fluorothymidin
  • Fluorothymidin F 18
  • ALOVUDINE F-18
Procedure: Positron Emission Tomography

Undergo FLT PET/CT

Andre navne:
  • Medicinsk billeddannelse, Positron Emission Tomografi
  • KÆLEDYR
  • PET-scanning
  • Positron Emission Tomografi Scan
  • Positron-emissionstomografi
  • PT
  • Positron emissionstomografi (procedure)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Negative Predictive Value of Post-treatment Fluorothymidine F 18 (FLT) Positron Emission Tomography (PET)/Computed Tomography (CT) Imaging for Complete Remission (CR) in Comparison With Blast Counts From Bone Marrow Biopsy (BMBX)
Tidsramme: Up to day 35

Three imaging parameters (standardized uptake value [SUV]mean, SUVmax, heterogeneity of FLT uptake [SUVhetero]) will be measured from an FLT PET/CT scan and SUVmax will be the primary endpoint. Higher values of SUVmax assume to indicate a non-response the therapy and a cut point of 7 (SUVmax >7) will be used as the threshold indicating a negative scan. The binomial proportion of negative predictive value (NPV) and the corresponding exact confidence intervals will be calculated. In addition, the calculated NPV will be tested against the null hypothesis to see if it's significantly larger than 0.64 (NPV of day-14 BMBX in CR prediction).

CR:Complete remission CRi: Complete remission with incomplete platelet recovery LFS: Leukemia-free state Non-responders defined as Not (CR,CRi,or LFS)

Negative predictive value (NPV) of the post-treatment FLT PET/CT scan is Probability ((not CR,CRi,or LFS) │ SUVmax >7 )
Up to day 35

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Positive Predictive Value (PPV) of Post-treatment FLT PET/CT Imaging for Complete Remission
Tidsramme: Up to day 35

The binomial proportion of PPV and the corresponding exact confidence intervals will be calculated. In addition, the calculated PPV will be tested to see if it's significantly larger than 0.79 (PPV of day-14 BMBX in CR prediction).
Up to day 35
Sensitivity of Post-treatment FLT PET/CT for Detecting Complete Remission (a Clinical Response of CR, CRi, or LFS )
Tidsramme: Up to day 35

The binomial proportions and the corresponding exact confidence intervals will be calculated for sensitivity estimation where

FLT Test :

Negative: SUV >7; Positive: SUV<=7

Clinical Response:

Negative: not (CR, CRi, or LFS); Positive (Responders): CR, CRi, or LFS
Up to day 35
Specificity of Post-treatment FLT PET/CT for Detecting Complete Remission
Tidsramme: Up to day 35

The binomial proportions and the corresponding exact confidence intervals will be calculated for specificity estimation.

Test response:

Negative: SUV >7; Positive: SUV<=7

Clinical Response = Complete remissions:

Negative (Non-Responders): not (CR, CRi, or LFS); Positive (Responders): CR, CRi, or LFS
Up to day 35
FLT PET/CT Imaging Parameters With Biologic Correlates (Minimal Residual Disease Assessment)
Tidsramme: Up to day 35

FLT PET/CT imaging features will be compared with biologic correlates (minimal residual disease [MRD] assessment).
Up to day 35
FLT PET/CT Imaging to Predict Relapse-free Survival
Tidsramme: Up to day 35 and up to 4 years for RFS

compare the Recurrence-Free Survival (RFS) between positive and negative post-treatment FLT PET/CT scans, where an SUVmax less than or equal to 7 (i.e., low FLT uptake) was considered a positive result, and an SUVmax greater than 7 (i.e., high FLT uptake) was a negative result.

Participants were followed for survival outcomes until study closure when the last participant has been followed for 1 year after study enrollment.

The relapse endpoint included both reappearance of blasts in the blood; and presence of more than 5% blasts not attributable to another cause Time-to-relapse was measured from the date of the remission bone marrow biopsy to the date of first recurrence or death, whichever came first.

RFS was only evaluable for participants with a clinical response of CR, CRi, or LFS at the remission bone marrow biopsy.
Up to day 35 and up to 4 years for RFS
FLT PET/CT Imaging to Predict Overall Survival
Tidsramme: Up to day 35 and up to 4 years for RFS

compare the Overall Survival (OS) between positive and negative post-treatment FLT PET/CT scans, where an SUVmax<= 7 (i.e., low FLT uptake) was considered a positive result, and an SUVmax > 7 (i.e., high FLT uptake) was a negative result.

Participants were followed for survival outcomes until study closure when the last participant has been followed for 1 year after study enrollment.
Up to day 35 and up to 4 years for RFS

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

National Cancer Institute (NCI)

Efterforskere

  • Ledende efterforsker: Robert Jeraj, ECOG-ACRIN Cancer Research Group

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

20. april 2016

Primær færdiggørelse (Faktiske)

31. december 2023

Studieafslutning (Anslået)

13. februar 2027

Datoer for studieregistrering

Først indsendt

18. marts 2015

Først indsendt, der opfyldte QC-kriterier

18. marts 2015

Først opslået (Anslået)

19. marts 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

23. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NCI-2015-00328
  • U10CA180820 (U.S. NIH-bevilling/kontrakt)
  • NCI-2015-00328 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • EAI141 (Anden identifikator: CTEP)
  • U10CA180827 (U.S. NIH-bevilling/kontrakt)
  • EAI141
  • EAI141 (Anden identifikator: ECOG-ACRIN Cancer Research Group)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner