- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02599974
PET-CT in the Initial Staging of Breast Cancer and in the Early Assessment of Response to Neoadjuvant Chemotherapy (ASAINT)
Role of Fluorodeoxyglucose (FDG) PET-CT in the Initial Staging of Breast Cancer (ASAINT 1) and in the Early Assessment of Response to Neoadjuvant Chemotherapy (ASAINT 2)
The two main objectives of this prospective study are:
- to identify those patients for whom pre-treatment FDG (Fluorodeoxyglucose) PET (positron emission tomography) CT-scan (Computed tomography scan) provides useful information for the treatment of breast cancer (ASAINT 1),
- to improve FDG PET-CT-scan imaging criteria for assessing response to neoadjuvant therapy early, in M0-patients (ASAINT 2).
The secondary objective is to better understand the interactions between the imaging parameters of FDG PET-CT-scan and biological and histological features of breast cancer .
This is a non-interventional study. Two PET-CT-scans are performed, one before starting treatment, and the other after 2 cycles of neoadjuvant chemotherapy. The two PET-CT-scans are prescribed by oncologists from the center of breast diseases Unit at St. Louis hospital, in Paris, France. Oncologists provide clear information to the patients on the purpose of the examination. The examinations are performed in the nuclear medicine department at St. Louis hospital. PET-CT-scans data, tumor characteristics, results of other imaging and biological tests, results of surgery and patient's follow-up are summarized in a "de-identified" file. This file has been declared to the National Commission on Informatics and Liberties (CNIL). The data in this file are established prospectively and secondary analyzed to assess the precise role of PET-CT-scans in the initial staging of breast cancer and to determine the optimal PET-CT-scans criteria to evaluate response to neoadjuvant treatment early.
연구 개요
상태
정황
연구 유형
등록 (예상)
연락처 및 위치
연구 장소
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Paris, 프랑스, 75010
- 모병
- Hopital Siant-louis
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연락하다:
- David Groheux, MD-PHD
- 전화번호: +33 630603009
- 이메일: david.groheux@aphp.fr
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria :
- Histologically confirmed breast cancer
- Stage II and III breast cancer
- Neo-adjuvant chemotherapy
- Baseline PET-CT-scan (ASAINT 1 and 2)
- PET-CT-scans after second cycle of neo-adjuvant chemotherapy (ASAINT 2)
- Tumor biopsy for diagnosis and biological analysis with hormone receptors and Human Epidermal Growth Factor Receptor-2 (HER2) available
- Surgical intervention after completion of neo-adjuvant chemotherapy
- Evaluable pathological response
Exclusion Criteria :
- Other tumor localization
- Non controlled diabetes mellitus
- Pregnancy
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Pathological complete response in M0 patients at baseline PET (stage II-III)
기간: 18 weeks
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Absence of residual cancer cells in the primary breast tumor and in axillary lymph nodes
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18 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Number of distant metastases (M1 patients at baseline PET)
기간: 2 weeks
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Detection of distant metastases by FDG PET-CT
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2 weeks
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Number of metastatic nodes at baseline PET (axillary and extra-axillary)
기간: 2 weeks
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Detection of metastatic axillary and extra-axillary nodes by FDG PET-CT
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2 weeks
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Standard uptake value on the FDG-PET (Fluorodeoxyglucose positron emission tomography)
기간: 2 weeks
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2 weeks
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Patients overall survival
기간: 5 years
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5 years
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event free survival
기간: 5 years
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5 years
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Patients overall survival
기간: 3 years
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3 years
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이벤트 프리 서바이벌
기간: 3년
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3년
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Patients overall survival
기간: 2 years
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2 years
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event free survival
기간: 2 years
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2 years
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Total lesion glycolysis on the FDG-PET (Fluorodeoxyglucose positron emission tomography)
기간: 2 weeks
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2 weeks
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Metabolic tumor volume on the FDG-PET (Fluorodeoxyglucose positron emission tomography)
기간: 2 weeks
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2 weeks
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Tumor heterogeneity determined on the FDG-PET (Fluorodeoxyglucose positron emission tomography)
기간: 2 weeks
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2 weeks
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공동 작업자 및 조사자
수사관
- 수석 연구원: David Groheux, MD-PhD, APHP, IUH, University Paris Diderot, Paris 7, SPC
- 연구 의자: Matthieu Resche-Rigon, MD-PHD, DRCD APHP Paris
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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. .