- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01527058
68Ga-BNOTA-PRGD2 PET/CT in Healthy Volunteers and Lung Cancer Patients (GRGDLC)
Radiation Dosimetry, Plasma Pharmacokinetics, Biodistribution, Safety and Diagnostic Performance of 68Ga-BNOTA-PRGD2 in Healthy Volunteers and Lung Cancer Patients
연구 개요
상세 설명
Integrin αⅤβ3 is an important member of this receptor family and expressed preferentially on various types of tumor cells and the activated endothelial cells of tumor angiogenesis, but not or very low on the quiescent vessel cells and other normal cells. Therefore, the integrin αⅤβ3 receptor is becoming a valuable target for diagnosis and response evaluation of malignant tumors.
The tri-peptide sequence of arginine-glycine-aspartic acid (RGD) can specifically bind to the integrin αⅤβ3 receptor. Accordingly, a variety of radiolabeled RGD-based peptides have been developed for non-invasive imaging of integrin αⅤβ3 expression via positron emission tomography (PET) or single photon emission computed tomography (SPECT). Among all the RGD radiotracers studied, two PET imaging agents, 18F-Galacto-RGD and 18F-AH111585, have been investigated in clinical trials, and the results demonstrated that both radiotracers allowed the specific imaging of various types of tumors, and the tumor uptake correlated well with the expression of integrin αⅤβ3. Recently, series of RGD dimeric peptides with PEG linkers have been studied. The new types of RGD peptides showed much higher in vitro integrin αⅤβ3-binding affinity than the single RGD tri-peptide sequence, and importantly, they exhibited significantly increased tumor uptake and improved in vivo kinetics in animal models. As a representative, 68Ga-BNOTA-PRGD2 could be easily prepared and exhibited excellent in vivo behaviors in animal models. No adverse reactions are observed in animal models to date.
For the further interests in clinical translation of 68Ga-BNOTA-PRGD2, a open-label dynamic whole-body PET/CT study was designed to investigate radiation dosimetry, plasma pharmacokinetics, biodistribution, safety and diagnostic performance of 68Ga-BNOTA-PRGD2 in healthy volunteers and lung cancer patients. A single dose of nearly 111 MBq 68Ga-BNOTA-PRGD2 ( ≤ 40 µg BNOTA-PRGD2) will be intravenously injected into healthy volunteers and lung cancer patients. Visual and semiquantitative method will be used to assess the PET/CT images. Changes of blood pressure, pulse, respiration, temperature, routine blood and urine tests, serum alanine aminotransferase, albumin, and creatinine, and any adverse events will be collected from the volunteers. Adverse events will also be observed in the patients.
연구 유형
등록 (예상)
단계
- 초기 1단계
연락처 및 위치
연구 연락처
- 이름: Fang Li, MD
- 전화번호: 86-10-65295502
- 이메일: lifang@pumch.cn
연구 연락처 백업
- 이름: Zhaohui Zhu, MD, PhD
- 전화번호: 86-10-13611093752
- 이메일: zzh_1969@yahoo.com.cn
연구 장소
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Beijing, 중국, 100730
- 모병
- Department of Nuclear Medicine, Peking Union Medical College Hopital
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수석 연구원:
- Fang Li, MD
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연락하다:
- Fang Li, MD
- 전화번호: 86-10-65295502
- 이메일: lifang@pumch.cn
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부수사관:
- Zhaohui Zhu, MD, PhD
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부수사관:
- Hongli Jing, MD
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
Healthy volunteers:
- Males and females, ≥30 and ≤ 70 years old
Cancer patients:
- Males and females, ≥30 years old
- CT and/or 18F-FDG PET/CT diagnosis in suspicion of primary or recurrent lung cancer.
- The lung cancer will be histologically confirmed or results of histology will be available.
Exclusion Criteria:
- Females planning to bear a child recently or with childbearing potential
- Renal function: serum creatinine >3.0 mg/dL (270 μM/L)
- Liver function: any hepatic enzyme level more than 5 times upper limit of normal.
- Known severe allergy or hypersensitivity to IV radiographic contrast.
- Patients not able to enter the bore of the PET/CT scanner.
- Inability to lie still for the entire imaging time because of cough, pain, etc.
- Inability to complete the needed examinations due to severe claustrophobia, radiation phobia, etc.
- Concurrent severe and/or uncontrolled and/or unstable other medical disease that, in the opinion of the Investigator, may significantly interfere with study compliance.
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: 68Ga-BNOTA-PRGD2 PET/CT scanning
Determine if 68Ga-BNOTA-PRGD2 PET/CT is safe and effective method for imaging of lung cancer
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Cancer patients, single intravenous bolus injection of nearly 111 MBq 68Ga-NOTA-PRGD2 on day one of the treatment period, dynamic whole-body PET/CT for determination of effective dose, kinetics of 68Ga-BNOTA-PRGD2 in blood, organs, and tumors Healthy volunteers, single intravenous bolus injection of nearly 111 MBq 68Ga-BNOTA-PRGD2 on day one of the treatment period, dynamic whole-body PET/CT for determination of effective dose, kinetics of 68Ga-BNOTA-PRGD2 in blood and organs
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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병변 및 생체분포의 시각적 및 반정량적 평가
기간: 1년
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육안 분석은 최소 3명의 숙련된 핵의학 의사가 합의 판독하여 수행합니다.
반정량적 분석은 모든 경우에 대해 동일한 사람이 수행하고 종양 및 장기의 표준화된 흡수 값(SUV)을 측정합니다.
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1년
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Blood pressure
기간: One year
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Blood pressure of healthy volunteers will be measured at three time points: right before injection, after scanning, and 24 hours after treatment.
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One year
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Pulse
기간: One year
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Pulse will be measured at three time points for each healthy volunteer: right before injection, after scanning, and 24 hours after treatment.
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One year
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Respiration frequency
기간: One year
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Respiration frequency will be measured at three time points for each healthy volunteer: right before injection, after scanning, and 24 hours after treatment.
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One year
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Temperature
기간: One year
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Temperature will be measured at three time points for each healthy volunteer: right before injection, after scanning, and 24 hours after treatment.
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One year
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Routine blood test
기간: One year
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Routine blood test of healthy volunteers will be measured at two time points: right before and 24 hours after treatment.
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One year
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Routine urine test
기간: One year
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Routine urine test of healthy volunteers will be measured at two time points: right before and 24 hours after treatment.
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One year
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Serum alanine aminotransferase
기간: One year
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Serum alanine aminotransferase of healthy volunteers will be measured at two time points: right before and 24 hours after treatment.
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One year
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Serum albumin
기간: One year
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Serum albumin of healthy volunteers will be measured at two time points: right before and 24 hours after treatment.
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One year
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Serum creatinine
기간: One year
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Serum creatinine of healthy volunteers will be measured at two time points: right before and 24 hours after treatment.
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One year
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Adverse events collection
기간: One year
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Adverse events within 5 days after the injection and scanning of healthy volunteers and patients will be followed and assessed.
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One year
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공동 작업자 및 조사자
수사관
- 연구 의자: Fang Li, MD, Department of Nuclear Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Science
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
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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68Ga-BNOTA-PRGD2에 대한 임상 시험
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Peking Union Medical College Hospital알려지지 않은
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Peking Union Medical College HospitalBeijing Tiantan Hospital알려지지 않은
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Peking Union Medical College Hospital알려지지 않은
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Peking University First HospitalXiangya Hospital of Central South University; Peking Union Medical College Hospital; Shanghai... 그리고 다른 협력자들알려지지 않은
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Peking Union Medical College Hospital모병
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Wuxi No. 4 People's Hospital알려지지 않은