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).
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Markeela Lipscomb
- 전화번호: 919-972-7440
- 이메일: markeela_lipscomb@med.unc.edu
연구 연락처 백업
- 이름: Kaila Brustkern
- 전화번호: 984-974-3226
- 이메일: kaila_brustkern@med.unc.edu
연구 장소
-
-
North Carolina
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Chapel Hill, North Carolina, 미국, 27599
- UNC Lineberger Comprehensive Cancer Center
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연락하다:
- Markeela Lipscomb
- 전화번호: 919-972-7440
- 이메일: markeela_lipscomb@med.unc.edu
-
연락하다:
- Kaila Brustkern
- 전화번호: 984-974-3226
- 이메일: kaila_brustkern@med.unc.edu
-
수석 연구원:
- Alexander Villalobos, MD
-
수석 연구원:
- Bryan Harris, MD
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
The number of successful novel blood oxygen level dependent (BOLD) magnetic resonance imaging (MRI)
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Hepatocellular carcinoma (HCC) hypoxia classification based on blood oxygen level dependent (BOLD) magnetic resonance imaging (MRI)
기간: 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
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Alexander Villalobos, MD, UNC Lineberger Comprehensive Cancer Center
- 수석 연구원: Bryan Harris, MD, UNC Lineberger Comprehensive Cancer Center
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- LCCC2446
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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