Characterizing Tumor Hypoxia With BOLD-MRI to Predict Y-90 Treatment Response (BOLDMRI)
Characterization of the Hypoxic Tumor Microenvironment With Blood Oxygen Level-Dependent Magnetic Resonance Imaging for the Prediction of Hepatocellular Carcinoma Response to Yttrium-90 Selective Internal Radiation Therapy
The purpose of this study is to find out whether a special type of magnetic resonance imaging ( MRI), called blood oxygen level-dependent (BOLD) MRI, can help measure how much oxygen is present in liver tumors. Tumors with low oxygen levels are described as being hypoxic.
Yttrium-90 (Y-90) is a type of radioactive material used to treat liver tumors, including hepatocellular carcinoma (HCC), a type of liver cancer. Y-90 is a form of radiation treatment delivered directly to liver tumors through tiny beads carried by blood vessels. These beads release radiation that damages and kills cancer cells while helping limit radiation exposure to surrounding healthy tissue. This treatment is also called Y-90 radioembolization or selective internal radiation therapy (SIRT).
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
The study will include 12 patients with liver tumors confirmed by biopsy to be hepatocellular carcinoma (HCC), a type of liver cancer, who are scheduled to receive Y-90 selective internal radiation therapy (SIRT), a treatment that delivers radiation directly to the tumor through blood vessels. Before treatment, participants will undergo a research MRI scan. A sample of their previously biopsied tumor tissue will also be examined in the laboratory to measure signs of low oxygen levels. The researchers will compare the MRI findings with the tissue results to determine whether BOLD MRI can reliably assess oxygen levels in liver tumors and may help predict how well the tumors respond to Y-90 treatment.
Standard-of-care Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE MRI) will be performed separately according to routine clinical practice before and after the Y90-SIRT procedure. BOLD MRI will be performed on a separate day after the pre-SIRT DCE MRI.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Markeela Lipscomb
- Telefonnummer: 919-972-7440
- E-post: markeela_lipscomb@med.unc.edu
Studer Kontakt Backup
- Navn: Kaila Brustkern
- Telefonnummer: 984-974-3226
- E-post: kaila_brustkern@med.unc.edu
Studiesteder
-
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North Carolina
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Chapel Hill, North Carolina, Forente stater, 27599
- UNC Lineberger Comprehensive Cancer Center
-
Ta kontakt med:
- Markeela Lipscomb
- Telefonnummer: 919-972-7440
- E-post: markeela_lipscomb@med.unc.edu
-
Ta kontakt med:
- Kaila Brustkern
- Telefonnummer: 984-974-3226
- E-post: kaila_brustkern@med.unc.edu
-
Hovedetterforsker:
- Alexander Villalobos, MD
-
Hovedetterforsker:
- Bryan Harris, MD
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
Subjects must meet all the inclusion criteria to participate in this study.
- Adults ≥ 18 years
- Liver mass(es) suspected of being HCC by imaging and are amenable to undergo percutaneous liver mass biopsy to confirm the HCC diagnosis, as determined by the institutional multidisciplinary tumor board.
- At least 1 tumor ≥ 2 cm and deemed to benefit from Y90 radioembolization by the institutional multidisciplinary tumor board.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2 (Karnofsky Performance Status (KPS) ≥60%)
- Life expectancy ≥6 months, as determined by the investigator.
Exclusion Criteria:
All subjects meeting any of the exclusion criteria at baseline will be excluded from study participation.
- Definite liver transplant candidate
- Concurrent secondary malignancy
- Distant metastasis
Studieplan
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: Hepatocellular carcinoma
Patients with hepatocellular carcinoma (HCC) who are scheduled to receive Y-90 selective internal radiation therapy (SIRT), |
BOLD MRI will include 2D and 3D multi-echo gradient-echo sequences covering the liver, using body phased-array coils and breath-hold techniques. Imaging parameters may be adjusted as needed to optimize tumor visualization while maintaining data quality. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
The number of successful novel blood oxygen level dependent (BOLD) magnetic resonance imaging (MRI)
Tidsramme: Baseline
|
The number of successful novel blood oxygen level dependent (BOLD) magnetic resonance imaging (MRI) method for evaluating the level of tumor tissue hypoxia in patients with liver tumors. |
Baseline
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Hepatocellular carcinoma (HCC) hypoxia classification based on blood oxygen level dependent (BOLD) magnetic resonance imaging (MRI)
Tidsramme: Baseline
|
Calculation of sensitivity, specificity, positive predictive value and negative predictive value of blood oxygen level dependent (BOLD) magnetic resonance imaging (MRI) based hepatocellular carcinoma (HCC) hypoxia classification. |
Baseline
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Alexander Villalobos, MD, UNC Lineberger Comprehensive Cancer Center
- Hovedetterforsker: Bryan Harris, MD, UNC Lineberger Comprehensive Cancer Center
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Neoplasmer etter nettsted
- Neoplasmer
- Neoplasmer etter histologisk type
- Neoplasmer i fordøyelsessystemet
- Sykdommer i fordøyelsessystemet
- Leversykdommer
- Neoplasmer, kjertel og epitel
- Adenokarsinom
- Karsinom
- Tegn og symptomer, luftveier
- Patologiske tilstander, tegn og symptomer
- Tegn og symptomer
- Karsinom, hepatocellulært
- Neoplasmer i leveren
- Hypoksi
- Diagnostiske teknikker og prosedyrer
- Diagnose
- Tomografi
- Diagnostisk avbildning
- Magnetisk resonansavbildning
Andre studie-ID-numre
- LCCC2446
Plan for individuelle deltakerdata (IPD)
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