- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03076333
PET/MR in Assessing Response to Neoadjuvant Radiation Therapy in the Tx of High Grade Sarcomas
Utility of PET/MR in Assessing Response to Neoadjuvant Radiation Therapy in the Treatment of High Grade Sarcomas
Purpose: To assess the utility of PET/MR in assessing response to neoadjuvant radiation therapy in the treatment of high grade sarcomas.
Participants: Adult patients with potentially curable high grade sarcomas that are being treated at UNC with neoadjuvant radiation therapy followed by potentially curative surgical resection.
Procedures (methods): Patients who are being treated for potentially curable high grade sarcomas with neoadjuvant radiation therapy followed by surgical resection undergo pre-treatment, mid-treatment, and post-treatment PET/MR and the response to treatment is assessed by evaluating change in size and FDG avidity. Patients then undergo curative intent resection and are followed. Their pathology is reviewed for treatment affect as is assessed by percent necrosis, size, and resection margins. Patients are followed and assessed for recurrence.
연구 개요
상세 설명
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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North Carolina
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Chapel Hill, North Carolina, 미국, 27599
- UNC-Chapel Hill
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Age ≥ 18 years of age (no upper age limit)
- Signed, IRB-approved written informed consent
- Must have a biopsy-proven high-grade retroperitoneal or soft tissue extremity sarcoma confirmed by independent evaluation of a UNC sarcoma specialized pathologist.
- Must have surgically curable disease as evaluated by initial imaging by our UNC surgeons.
- Must be in acceptable health to undergo radiation therapy and curative intent surgery as assessed by UNC surgeons and radiation oncologist.
- Must be able to understand and comply with study procedures for the entire length of the study.
- Must receive their neoadjuvant radiation therapy and curative intent surgery at UNC Hospitals - Chapel Hill location.
- Women of childbearing potential must have a negative serum or urine pregnancy test performed within 7 days prior to each PET/MRI
Exclusion Criteria:
- Inability to tolerate MRI (e.g., inability to lie flat for >1 hour)
- Presence of pacemaker, intracranial aneurysm clip, bladder stimulator, cochlear implant or metal near eyes or near pelvis that would create excessive imaging artifact
- Poorly controlled diabetes mellitus
- Creatinine > 1.8 mg/dL OR GFR < 30mL/min
- Body Mass Index (BMI) > 35
- Active vaginal bleeding requiring packing and emergent radiation therapy
- Pregnancy or lactating female
- History of a prior malignancy within past 5 years are excluded unless they have been disease free for 3 or more years
- Substance abuse, medical, psychological, or social conditions that may interfere with the patient's participation in the study
- Evidence of distant disease on physical exam or initial imaging
- Medical conditions precluding radiation therapy or curative intent surgery
- Previous radiation exposure precluding radiation therapy
- Had serious reaction to contrast agent
- Incarcerated or otherwise institutionalized at time of enrollment
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 |
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실험적: Single Arm: PET/MR
Each patient will undergo three combined PET/MR scans.
The pre-treatment PET, mid-treatment PET and MR, and post-treatment PET are for research purposes and not part of the patient's standard of care (pre-treatment MR and post-treatment MR).
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Patient will be scheduled for a pre-treatment PET/MR and proceed to neoadjuvant radiation therapy per the direction of the radiation oncologist.
At the end of the second week of radiation therapy the patient will undergo a mid-treatment PET/MR.
The patient will the complete their radiation therapy.
Four weeks after radiation therapy the patient will undergo a post-treatment PET/MR, and proceed for curative intent surgery at 6-8 weeks post radiation if they are still surgical candidates.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
PET Activity Estimates at Midpoint of Treatment as Compared to Baseline
기간: At the end of the second week of radiation therapy, a mid-treatment PET/MR is obtained.
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Primary endpoint is the determination of differences among response groups in PET activity estimates from PET/MR imaging at the midpoint of treatment as compared to baseline.
The measure is computed as the change in mean SUV from the baseline PET-MR scan to the scan at the end of the second week of therapy.
Treatment response will be determined on final pathological evaluation of the resected specimens in patients who undergo curative intent surgery after neoadjuvant radiation in high grade sarcomas.
This will be measured by a single sarcoma specialized pathologist and will be categorized as to the percentage of necrosis, with >90% necrosis considered to be complete response.
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At the end of the second week of radiation therapy, a mid-treatment PET/MR is obtained.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
PET Activity Estimates at Endpoint of Treatment as Compared to Baseline
기간: A post-treatment PET/MR is obtained at 4 weeks post radiation.
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A secondary endpoint is the determination of differences among response groups in PET activity estimates from PET/MR imaging at the endpoint of treatment as compared to baseline.
The measure is computed as the change in mean SUV from the baseline PET-MR scan to the scan taken four weeks after completion of therapy.
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A post-treatment PET/MR is obtained at 4 weeks post radiation.
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공동 작업자 및 조사자
수사관
- 수석 연구원: David Lalush, PhD, UNC Biomedical Engineering
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 (실제)
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
- LCCC 1615
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
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. .
PET/MR에 대한 임상 시험
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Norwegian University of Science and TechnologyUniversity Hospital of North Norway; Haukeland University Hospital; St. Olavs Hospital완전한
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