Image-Based Quantitative Assessment of Acute Radiation-Induced Changes in Glioma
연구 개요
상세 설명
Once eligibility criteria have been assessed and the informed consent is obtained, participants will undergo a screening process to further ensure eligibility. Screening prior to registration will comprise a review of pathology reports, postoperative magnetic resonance Imaging (MRI) images, operative reports, and medical history; general physical and neurologic exams; routine blood work; and urine pregnancy test for women of childbearing age.
The study is intended to evaluate the response of radiation treatment (RT). The consent process will be performed between the surgery and the start of RT. RT will be prescribed as per the discretion of the treating radiation oncologist as per the University of Alabama at Birmingham Department of Radiation Oncology treatment protocol in combination with temozolomide.
MRIs will be obtained before start of RT, after completion of 20 +/- 4 Gy. after completion of 40+/- 4 Gy and after the entire radiation treatment. Conventional MRIs including perfusion sequences and whole brain spectroscopy will be performed as a part of the research study. The data obtained from this research studies will not be used for clinical management.
Volumes of the enhancing component, non enhancing component, choline/N-acetyl aspartate (Cho/NAA) will be measure before, during and after RT as described before. Cerebral blood volume (CBV) of the tumor will also be calculated from perfusion imaging at each time point. Apparent diffusion co-efficient (ADC) of the tumor will be calculated from the diffusion imaging.
All the patients will be followed up with imaging and will be treated as per the standard of care. Patients will return for clinical evaluation and standard of care imaging approximately 4 weeks from the completion of the radiation therapy. After that, all the patients will be treated with standard of care maintenance temozolomide therapy and will return every 2-3 months for clinical evaluation and standard of care imaging.
At the time of recurrence, the recurrence site will be assessed and will be compared with the imaging parameters obtained during radiation treatment. Time to recurrence will also be calculated and will be correlated with the imaging parameters.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Alabama
-
Birmingham, Alabama, 미국, 35249
- University of Alabama at Birmingham
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Newly diagnosed glioma, based on pathology confirmation;
- At least 8 cm3 of residual enhancing tumor after surgery or significant visible tumor (As seen on immediate postoperative scan);
- Scheduled to receive standard fractionated RT with concomitant temozolomide therapy;
- Karnofsky Performance Score > 60.
Exclusion Criteria:
- Scheduled to receive investigational chemotherapy, immunotherapy, or any other investigational agents;
- Placement of GLIADEL® wafer in the resection cavity;
- Significant amount of hemorrhage within the resection cavity (seen on immediate post-operative scan);
- A large peritumoral infraction related to surgery (identified by new confluent diffusion restriction);
- Not suitable to undergo MRI or use the MRI contrast agent (GFR<30 mL/min/1.73 m2); or the patient has known anaphylactic reaction to gadolinium based contrast agents.
- Presence of serious systemic illness, including: uncontrolled infection, uncontrolled malignancy, significant renal disease, or psychiatric/social situations, which might impact the survival endpoint of the study or limit compliance with study requirements.
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: Chemoradiation with MRI assessment
This study has only one arm.
The eligible subjects will receive standard of care fractionated radiation therapy along with concomitant temozolomide, which will NOT be changed based on the MRI scans obtained as a part of this study.
There is no control or sham group.
|
Standard of care fractionated radiation therapy will be given to the tumor.
Standard of care temozolomide will be given along with radiation therapy
다른 이름들:
Four MRI scan will be performed according to the protocol.
The first one will be obtained before start of radiation therapy, the second MRI will be obtained after completion of 20 +/- 4 Gy, the third MRI will be obtained after completion of 40 +/- 4 Gy, and the final MRI will be obtained after completion of the radiation therapy.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Number of Participants With the Changes of the Chemical Environment of the Tumor
기간: From Baseline to 6 weeks.
|
Multiple MRI techniques will be used to assess chemical environment (Cho/NAA) of the tumor during the course of fractionated radiation treatment.
|
From Baseline to 6 weeks.
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Changes of Tumor Cellularity
기간: From baseline to 6 weeks
|
Diffusion MRI will be used for assessment of measures tumor cellularity (with minimum apparent diffusion co-efficent, ADC) during the course of fractionated radiation treatment.
|
From baseline to 6 weeks
|
|
Changes of Tumor Volume
기간: From baseline Up to 6 weeks
|
MRI will be used for assessment of measures tumor volume.
|
From baseline Up to 6 weeks
|
|
Changes of Tumor Angiogenesis
기간: From baseline to 6 weeks
|
Perfusion MRI will be used for assessment of tumor angiogenesis (with median normalized cerbral blood volume, nCBV) during the course of fractionated radiation treatment.
|
From baseline to 6 weeks
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Time to Progression
기간: From Baseline through 24 months.
|
Percentage change of the Cho/NAA, ADC and nCBV from baseline to the end of radiation therapy, RT will be used for assessment of time to progression.
|
From Baseline through 24 months.
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Asim Bag, MD, University of Alabama at Birmingham
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
- F160324004
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. .
Fractionated Radiation에 대한 임상 시험
-
University of Texas Southwestern Medical Center모집하지 않고 적극적으로
-
University of Texas Southwestern Medical Center모집하지 않고 적극적으로
-
Indiana UniversityIndiana University School of Medicine종료됨
-
Sunnybrook Health Sciences CentreProstate Cancer Canada알려지지 않은
-
Alpha Tau Medical LTD.European Organisation for Research and Treatment of Cancer - EORTC아직 모집하지 않음
-
University of North Carolina, Chapel HillNational Heart, Lung, and Blood Institute (NHLBI)모병
-
Alpha Tau Medical LTD.모병