NCT06455761 68Ga-DOTA-NI-FAPI04 PET/CT in Patients With Various Types of Cancer
| NCT ID | NCT06455761 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | First Affiliated Hospital of Fujian Medical University |
| Condition | Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-04-01 |
| Primary Completion | 2025-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 30 participants in total. It began in 2024-04-01 with a primary completion date of 2025-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
As a novel radiotracer targeting fibroblast activation protein (FAP), 68Ga-DOTA-NI-FAPI04 is a novel agent incorporating a hypoxia sensitive nitroimidazole(NI)-moiety and a FAP-targeting. In this study, we observed the diagnostic performance of 68Ga-DOTA-NI-FAPI04 PET/CT in patients with different types of cancer, and compared its imaging results with those of 68Ga-FAPI or 18F-FDG PET/CT.
Eligibility Criteria
Inclusion Criteria: Various solid tumors with available histopathological findings; Signed informed consent. Exclusion Criteria: pregnant or lactational women; who suffered from severe hepatic and renal insufficiency.
Contact & Investigator
Weibing Weibing, MD
PRINCIPAL INVESTIGATOR
First Affiliated Hospital of Fujian Medical University
Frequently Asked Questions
Who can join the NCT06455761 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06455761 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06455761 currently recruiting?
Yes, NCT06455761 is actively recruiting participants. Contact the research team at miaoweibing@126.com for enrollment information.
Where is the NCT06455761 trial being conducted?
This trial is being conducted at Fuzhou, China.
Who is sponsoring the NCT06455761 clinical trial?
NCT06455761 is sponsored by First Affiliated Hospital of Fujian Medical University. The principal investigator is Weibing Weibing, MD at First Affiliated Hospital of Fujian Medical University. The trial plans to enroll 30 participants.