NCT04499365 68Ga-FAPI PET/CT in Patients With Various Types of Cancer
| NCT ID | NCT04499365 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | First Affiliated Hospital of Fujian Medical University |
| Condition | Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 500 participants |
| Start Date | 2020-08-15 |
| Primary Completion | 2027-12-30 |
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 500 participants in total. It began in 2020-08-15 with a primary completion date of 2027-12-30.
⚠ 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
To evaluate the potential usefulness of 68Ga-DOTA/NOTA-FAPI-04 positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in various types of cancer.
Eligibility Criteria
Inclusion Criteria: * (i) adult patients (aged 18 years or order); (ii) patients with suspected or new diagnosed or previously treated malignant tumors (supporting evidence may include MRI, CT, tumor markers and pathology report); (iii) patients who had scheduled 68Ga-DOTA/NOTA-FAPI-04 PET/CT scan; (iv) patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee. Exclusion Criteria: * (i) patients with non-malignant lesions; (ii) patients with pregnancy; (iii) the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04499365 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 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 NCT04499365 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 NCT04499365 currently recruiting?
Yes, NCT04499365 is actively recruiting participants. Contact the research team at miaoweibing@126.com for enrollment information.
Where is the NCT04499365 trial being conducted?
This trial is being conducted at Fuzhou, China.
Who is sponsoring the NCT04499365 clinical trial?
NCT04499365 is sponsored by First Affiliated Hospital of Fujian Medical University. The trial plans to enroll 500 participants.