- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01395030
PET/CT in Diagnosing Patients With Liver Cancer Undergoing Surgical Resection
Genomic and Imaging Study for Patients Undergoing Surgery for Liver Cancer
연구 개요
상태
상세 설명
PRIMARY OBJECTIVES:
I. Determine the most optimal fluorine-18 (18F) fluoromethylcholine (FCH) PET/CT parameters for detecting primary hepatocellular carcinoma (HCC) by conducting a clinical radiologic-pathologic correlation study to estimate and compare the receiver operating characteristics of kinetic and static PET measures of tumor FCH metabolism in patients that test positive during screening or conventional imaging.
II. Identify cancer signaling pathways associated with choline metabolism in HCC by profiling the global gene expression patterns in fresh-frozen liver tissue samples that are correlated with the features derived from FCH PET/CT images.
III. Characterize the association between features derived from FCH PET/CT images of the liver and clinical liver disease severity and comparatively evaluate the ability of corresponding gene expression signatures to predictively model HCC disease outcome.
OUTLINE:
Patients undergo 18F-fluoromethylcholine PET/CT within 14 days of surgical resection.
After completion of study treatment, patients are followed up periodically.
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
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Hawaii
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Honolulu, Hawaii, 미국, 96813
- University of Hawaii Cancer Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Liver tumor diagnosed histologically as HCC or suspected of being HCC in association with serum alpha-fetoprotein level > 200 or tumor mass with characteristics of malignancy on diagnostic imaging
- Under the care of a surgical attending
- Deemed a surgical candidate and has agreed to surgery to remove a portion of the liver containing tumor
- Child-Pugh A/B
Exclusion Criteria:
- Weight > 350 lbs
- Pregnant or lactating female, a serum pregnancy test will be performed within 2 weeks or less before the date of the FCH PET/CT scan in all women capable of becoming pregnant
- Serious underlying medical condition that would impair patient's ability to tolerate the imaging procedure
- Concurrent treatment with chemotherapy, molecule-selective, biological, or radiotherapeutic agent
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: 18F-fluoromethylcholine PET/CT
Patients undergo 18F-fluoromethylcholine positron emission tomography (PET)/ computed tomography (CT) scan within 14 days of surgical resection of liver tumor.
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Undergo FCH PET/CT
다른 이름들:
Undergo FCH PET/CT
다른 이름들:
Undergo FCH PET/CT
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Fluorine-18 (18F) Fluoromethylcholine (FCH) PET/CT Parameters for Assessing Hepatocellular Carcinoma (HCC): Area Under the Receiver Operating Characteristic Curve.
기간: Up to study completion at an average of 2.5 years
|
Area under the receiver operating characteristic curve for detecting resectable hepatocellular carcinoma with prognostically favorable molecular features (Hoshida molecular sub-class S3) based on FCH PET/CT measurement of tumor maximum standardized uptake value (SUVmax).
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Up to study completion at an average of 2.5 years
|
Fluorine-18 (18F) Fluoromethylcholine (FCH) PET/CT Parameters for Assessing Hepatocellular Carcinoma (HCC): Sensitivity/Specificity
기간: Up to study completion at an average of 2.5 years
|
Sensitivity and specificity estimated at a predefined point (ie.
Youden's maxima) on the receiver operating characteristic curve for detecting hepatocellular carcinoma with prognostically favorable molecular features (Hoshida molecular sub-class S3) based on FCH PET/CT measurement of tumor maximum standardized uptake value (SUVmax) in patients who underwent subsequent tumor resection.
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Up to study completion at an average of 2.5 years
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Statistical Significance of Molecular Pathways Associated With Choline Metabolism as Identified Through Gene Set Enrichment Analysis of Hepatocellular Carcinoma (HCC) Tumor Samples.
기간: Up to study completion at an average of 2.5 years
|
Statistically significant enrichment by sets of genes corresponding to previously-defined molecular pathway signatures was assessed by gene set enrichment analysis (a publicly available algorithm) of whole-genome expression array data obtained from tumors previously characterized by FCH PET/CT.
Statistical significance was based on a false discovery rate < 0.05.
Tumors demonstrating high choline metabolism (defined by a tumor-liver ratio > 1.0 measured on PET) were assessed for enrichment by publicly-available gene sets.
This particular analysis involved the entire Molecular Hallmarks gene signature collection (v6.0) as obtained from the Broad Institute Molecular Signature Database (MSigDB).
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Up to study completion at an average of 2.5 years
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Clinical Liver Disease Severity Based on Liver Fibrosis (Metavir) Stage
기간: Up to 1 year
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Odds ratios and 95% confidence intervals for histologic liver fibrosis (Metavir) stage >= F1, >= F2, >= F3, and F4 at liver standardized uptake value (SUV) thresholds of 8.3, 8.0, 7.4, and 6.4, respectively.
Reference: PMID 29315063.
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Up to 1 year
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Number of Participants Comprising Two Distinct PET/CT Imaging Phenotypes (High FCH Uptake vs. Low FCH Uptake) Between the Different Tumor Sub-classes
기간: Up to study completion at an average of 2.5 years
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HCC tumors were sub-classified using gene expression arrays into 3 distinct prognostically-relevant molecular sub-classes (S1,S2, S3, where S3 is associated with the most favorable clinical prognosis) based on Hoshida et.
al (PMID 19723656).
The number of tumors comprising two distinct PET/CT imaging phenotypes (high FCH uptake vs. low FCH uptake) was compared between the different sub-classes.
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Up to study completion at an average of 2.5 years
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공동 작업자 및 조사자
수사관
- 수석 연구원: Sandi Kwee, MD, Queen's Medical Center
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- RA-2011-025 (기타 식별자: Queen's Medical Center)
- NCI-2012-02095 (레지스트리 식별자: CTRP (Clinical Trial Reporting Program))
- CHS-19373 (기타 식별자: University of Hawaii)
- R01CA161209 (미국 NIH 보조금/계약)
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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