A Post Approval Study to Evaluate Safety and Effectiveness of Multicompartmental Dosimetry Planning. (ADVANCE-MCD)
A Post Approval Single-arm Study Evaluating Transarterial Radioembolization Treatment for Hepatocellular Carcinoma Using Multicompartment Dosimetry Planning
The purpose of this study is to assess the safety and effectiveness of treating a tumor using a different planning method called MCD for the FDA-Approved device, TheraSphere.
TheraSphere Microspheres are microscopic radioactive glass spheres that deliver radiation therapy in the liver tissue where they are placed. This study investigates a procedure called multicompartment dosimetry (MCD). When using a multicompartment dosimetry approach, the doctor will look at images of the liver to see where there is tumor to determine where to treat. That area will be divided into "compartments" where the dose to tumor and the healthy liver are calculated separately. The goal of MCD is to give the tumor a higher radiation dose while protecting more of the healthy part of the liver.
Traditional planning for the TheraSphere Microspheres procedure uses single compartment dosimetry (SCD) which treats the tumor and the healthy liver as one area so the dose is more evenly distributed and the dose to the tumor may be lower than with the MCD approach. The single compartment approach is standard and is well established however this research study is to see if giving TheraSphere Microspheres with an MCD planning method is safe and effective by evaluating the effect of radiation on the liver as well as how the tumor responds to higher doses
연구 개요
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Natalie Lydon, MHA
- 전화번호: +1 (612) 240-6364
- 이메일: natalie.lydon@bsci.com
연구 연락처 백업
- 이름: Krista Asmus, MPH
- 전화번호: +1 (952) 356-9553
- 이메일: krista.asmus@bsci.com
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- TheraSphere Microspheres treatment determined as the optimal therapy
- Have unresectable solitary HCC
- Treatment Naïve
- ECOG 0 or 1
- Adequate liver function
- Adequate renal and marrow function
- Negative pregnancy test and/or adequate contraception for the patient and his/her sexual partner
Exclusion Criteria:
- Macrovascular invasion
- Extrahepatic metastases
- Previous or current ascites/encephalopathy
- Previous liver radiation, TACE, or systemic therapy for the disease
- History of organ allograft including bone marrow
- Any significant comorbities or contraindications to TheraSphere
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
Unresectable Hepatocellular Carcinoma
Patients with unresectable hepatocellular carcinoma (HCC) with tumor sizes 1-8cm.
Patients will be candidates for TheraSphere Microspheres and planning to undergo the procedure as part of their treatment plan.
|
Placement of TheraSphere Microspheres into the area of the primary tumor using multicompartment dosimetry instead of single compartment dosimetry
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Primary Safety Endpoint
기간: 4 months
|
The rate of Radioembolization Induced Liver Disease (REILD) Grade ≥3 occurring up to 4 months after any TheraSphere Microspheres treatment administration before progression.
|
4 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Secondary Safety Endpoint
기간: 13 months
|
Number of device- and/or procedure-related adverse events (AEs) and serious adverse events (SAEs), measured by count (number of events).
|
13 months
|
|
Secondary Safety Endpoint
기간: 13 months
|
Change from baseline in Albumin Bilirubin (ALBI) score, measured using the ALBI index.
|
13 months
|
|
Secondary Safety Endpoint
기간: 13 months
|
Most severe grade of hepatotoxicity following radioembolization, assessed using CTCAE grading criteria.
|
13 months
|
|
Secondary Effectiveness Endpoint
기간: 13 months
|
Objective Response Rate (ORR) as assessed by localized mRECIST criteria.
|
13 months
|
|
Secondary Effectiveness Endpoint
기간: 13 months
|
Duration of Response (DoR) evaluated by localized mRECIST and mRECIST criteria.
|
13 months
|
|
Secondary Effectiveness Endpoint
기간: 13 months
|
Number of patients who become eligible for liver transplantation or liver resection following treatment, measured by total count (number of patients).
|
13 months
|
|
Secondary Effectiveness Endpoint
기간: 13 months
|
Histopathologic response assessment in patients who undergo surgical resection, collected through descriptive and categorial data points.
|
13 months
|
|
Secondary Effectiveness Endpoint
기간: 13 months
|
Overall Survival (OS), defined as the time from treatment initiation to death from any cause, measured in months.
|
13 months
|
공동 작업자 및 조사자
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
기타 연구 ID 번호
- S10104
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
미국에서 제조되어 미국에서 수출되는 제품
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. .
간세포 암종(HCC)에 대한 임상 시험
-
Guangzhou Virotech Pharmaceutical Co., Ltd.모병
-
University of PisaAzienda Ospedaliera Città della Salute e della Scienza di Torino; Fondazione Policlinico... 그리고 다른 협력자들모병
-
Huazhong University of Science and Technology알려지지 않은
-
Leiden University Medical CenterMedtronic; ZonMw: The Netherlands Organisation for Health Research and Development; Maag... 그리고 다른 협력자들완전한
-
IRCCS Azienda Ospedaliero-Universitaria di Bologna모병
TheraSphere에 대한 임상 시험
-
Boston Scientific Corporation모집하지 않고 적극적으로
-
University of LouisvilleMDS Pharma Services완전한
-
Boston Scientific Corporation모병교모세포종 다형 | 재발성 교모세포종미국
-
Fondazione IRCCS Istituto Nazionale dei Tumori,...Gastro Intestinal Surgery and Liver Transplantation; The Hepato-Oncology Group: Department...완전한
-
Boston Scientific CorporationBiocompatibles UK Ltd종료됨
-
University of California, San Francisco아직 모집하지 않음
-
Northwestern UniversityBTG International Inc.종료됨
-
University of MiamiImmunocore Ltd모병