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임상시험 NCT07385950은(는) PET / CT, 고형 종양들, 성인에 대해 대상자모집전 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
하나의 임상시험이 필터 기준과 일치합니다.
카드 뷰
Evaluation of the Diagnostic Efficacy of a αvβ6/FAP-Targeting Heterodimeric Probe in Patients With Malignant Solid Tumors 100 비침습 신규 요법 맞춤형 치료
임상시험 세부 정보는 주로 영어로 제공됩니다. 하지만 임상 레이더 AI가 도와드릴 수 있습니다! '임상시험 설명'를 클릭하여 선택한 언어로 임상시험 정보를 확인하고, 이에 대해 AI와 논의해 보세요.
임상시험 NCT07385950은(는) PET / CT, 고형 종양들, 성인에 대해 알아보는 관찰연구입니다. 현재 상태는 대상자모집전이며, 2026년 1월 15일부터 참여 신청이 가능합니다. 100명의 참여자를 모집할 예정입니다. Zhongnan Hospital이(가) 진행하는 이 연구는 2028년 12월 31일까지 진행될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2026년 2월 4일에 갱신되었습니다.
간단한 개요
Malignant tumors pose a grave threat to human health and impose a substantial burden on society. Molecular imaging, which enables non-invasive, in vivo visualization of biological processes at the molecular level, is crucial for early diagnosis and treatment monitoring, thereby improving clinical management. Currently, molecular probes targeting fibroblast activation protein (FAP) and integrin αvβ6, such as ⁶⁸Ga-labe...더 보기
상세한 설명
This investigator-initiated trial (IIT) aims to evaluate the clinical utility of positron emission tomography (PET) imaging targeting both integrin αvβ6 and fibroblast activation protein (FAP) in patients with malignant solid tumors. Based on promising preclinical studies, we have designed and synthesized a bispecific probe, B6FA-01, which can simultaneously bind to both targets. By concurrently targeting two indepen...더 보기
공식 제목
Evaluation of Diagnostic Efficacy of a αvβ6/FAP-Targeting Heterodimeric Probe in Patients With Malignant Solid Tumors: An Open-Label, Single-Arm, Single-Center Study
질환명
PET / CT고형 종양들성인출판물
이 임상시험에 대해 발표된 과학 논문 및 연구 자료.기타 연구 식별자
- IIT2025383
NCT 번호
실제 연구 시작일
2026-01-15
최신 업데이트 게시
2026-02-04
예상 연구 완료일
2028-12-31
계획된 등록 인원
100
연구종류
관찰연구
상태
대상자모집전
키워드
integrin αVβ6
FAP
PET imaging
Diagnostic efficacy
FAP
PET imaging
Diagnostic efficacy
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
Recipients with Malignant solid tumors Participants:
Patients (≥18 years) with highly suspected or pathologically confirmed malignant tumors, or patients with suspected recurrence of malignant tumors after treatment
Interventions:
68Ga-B6FA-01 PET/CT scan prior to therapy.
Objectives:
* Evaluate the diagnostic efficacy of 68Ga-B6FA-01 PET in malignant solid tumors.
* Evaluate the safety and tolerability, biological distribution, radiation dose, and p...더 보기 | PET/CT Imaging with αvβ6/FAP-targeted tracer Intravenous administration of αvβ6/FAP-targeted tracer (111\~185 MBq), followed by whole-body PET/CT scan 30\~60 minutes post-injection. |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
The diagnostic sensitivity and specificity of 68Ga-B6FA-01 PET/CT in the staging of malignant tumors | To assess the he diagnostic performance of 68Ga-B6FA-01 PET/CT in patients with newly diagnosed malignancies. Accuracy will be evaluated using a composite reference standard, including histopathological confirmation, clinical follow-up, and additional imaging findings. | 3 years |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
The connection between B6FA-01 PET parameters and histopathological biomarkers. | Analyze the correlation between B6FA-01 PET parameters (SUVmax/SUVmean/SUVpeak, measured in the Syngo Workstation (Siemens Healthineers)) and FAP and αVβ6 expression levels (H-score; immunohistochemistry) or immune - related biomarkers, such as PD-L1 expression (Combined Positive Score; Dako 22C3 IHC assay), CD8 expression (H-score; immunohistochemistry). | Within 4 weeks of B6FA-01 PET scan |
참여 도우미
적격성 기준
연령대
성인, 노인
최소 연령
18 Years
참여 가능한 성별
전체
- Voluntarily provide written informed consent.
- Age ≥ 18 years.
- Newly diagnosed with a clinically/radiologically suspected or pathologically confirmed malignant solid tumor, or with suspected recurrence after prior treatment.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1.
- Life expectancy > 6 months.
- Participants of childbearing potential and their partners must agree to use highly effective contraception for 6 months following the last dose of the investigational agent.
- Prior radioisotope therapy within an interval less than 10 times the physical half-life of the respective radionuclide before study administration.
- Concurrent participation in any other interventional clinical trial.
- Known allergy or hypersensitivity to the investigational agent or any of its excipients.
- Inability to lie still for the duration of the PET scan or any condition contraindicating PET imaging.
- Pregnancy or lactation.
- Any other condition that, in the investigator's judgment, would compromise participant safety or study integrity.
Zhongnan Hospital연구 책임자
Yong He, 책임연구자, Department of Nuclear Medicine, Zhongnan Hospital of Wuhan University
연구 대표 연락처
연락처: Yong He, MD, PhD, +86-27-67812698, [email protected]
1 1개국에 임상시험 장소
Hubei
Zhongnan Hospital of Wuhan University, Wuhan, Hubei, 430071, China
Yaqun Jiang, MD, PhD, 연락처, +86 27 67812698, [email protected]