- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00989105
Technetium Tc 99m Demobesin-4 for Imaging Procedures in Patients With Prostate Cancer
A Cancer Research UK Phase I Trial of 99mTc Demobesin-4 (a Diagnostic Radiopharmaceutical) Given Once Via Bolus Intravenous Injection for Imaging of Prostate Cancer
RATIONALE: Diagnostic procedures, such as technetium Tc 99m demobesin-4 followed by single-photon emission computer tomography, CT scan, and MRI, may help find prostate cancer and learn the extent of disease.
PURPOSE: This phase I trial is studying the side effects of technetium Tc 99m demobesin-4 and to see how well it works for imaging procedures in patients with prostate cancer.
연구 개요
상태
정황
상세 설명
OBJECTIVES:
Primary
- To assess the safety of technetium Tc 99m (^99mTc) demobesin-4 (DB4) in patients with prostate cancer.
- To assess the biodistribution of ^99mTc DB4 in these patients.
- To assess the pharmacokinetics of ^99mTc DB4 in these patients.
Secondary
- To assess the performance of ^99mTc DB4 in detecting metastatic spread of prostate cancer in these patients.
Tertiary
- To compare uptake of ^99mTc DB4 with levels of expression in gastrin-releasing peptide receptor in prostate tumor samples and lymph node specimens.
OUTLINE: Patients are stratified according to diagnosis (cancer confined to prostate vs locally advanced disease vs metastatic disease).
Patients receive technetium Tc 99m (^99mTc) demobesin-4 (DB4) IV bolus over 1 minute and undergo imaging by single photon emission computer tomography, CT scan, and/or MRI up to 3 hours after infusion. Some patients undergo radical prostatectomy or surgical pelvic lymph node biopsies.
Blood and urine samples are collected at 5, 10, 20, 30, and 45 minutes at baseline and at 1, 2, 3, 4, and 6 hours after ^99mTc DB4 IV infusion for pharmacokinetic studies. Tumor tissue samples obtained during radical prostatectomy and surgical lymph node biopsies are analyzed for gastrin-releasing peptide receptor by IHC.
After completion of study intervention, patients are followed for up to 28 days.
Peer Reviewed and Funded or Endorsed by Cancer Research UK.
연구 유형
등록 (실제)
단계
- 1단계
연락처 및 위치
연구 장소
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England
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London, England, 영국, EC1A 7BE
- Saint Bartholomew's Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
DISEASE CHARACTERISTICS:
Histologically confirmed prostate cancer meeting 1 of the following criteria:
- Disease confined to the prostate that is to be treated with radical prostatectomy after imaging
Locally advanced disease that is to be treated with radiotherapy
- Patients must agree to undergo surgical pelvic lymph node staging to assist with determination of radiation fields
Metastatic disease at initial diagnosis or recurrent or progressive disease
- Patients receive standard of care
PATIENT CHARACTERISTICS:
- WHO performance status 0-2
- Neutrophils ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 9.0 g/dL
- Serum bilirubin ≤ 1.5 times upper limit of normal (ULN)
- Serum creatinine ≤ 1.5 times ULN
- Must be registered with the Cancer Research UK Drug Development Office
- Capable of cooperating with imaging procedure and follow-up
- Fertile patients must use effective contraception during and for 6 months after completion of study therapy
- Not at high medical risk because of non-malignant systemic disease, including active uncontrolled infection
- No history of recent significant cardiac arrhythmia
- No prior NYHA class III-IV cardiac disease or concurrent congestive heart failure
- No other condition that, in the Investigator's opinion, would not make the patient a good candidate for the clinical trial
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No chemotherapy or radiotherapy prior to or within 2 weeks of study therapy
- No prior major thoracic and/or abdominal surgery from which the patient has not yet recovered
- No other concurrent investigational drugs
- Concurrent anticancer therapy allowed
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 마스킹: 없음(오픈 라벨)
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
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Causality of each adverse events as assessed by NCI CTCAE v. 3.0
|
Biodistribution of radioactivity of 99mTc DB4 by gamma-camera imaging
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Pharmacokinetics of 99mTc DB4 in blood and urine and assessment of decline over 6 hours
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2차 결과 측정
결과 측정 |
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Performance of 99mTc DB4 gamma-camera imaging compared with conventional imaging (CT scan and/or MRI)
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Levels of expression in gastrin-releasing peptide in prostate tumor samples and lymph node specimens
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공동 작업자 및 조사자
수사관
- 수석 연구원: Norbert Avril, MD, St. Bartholomew's Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작
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 (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. .
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