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NCT04457232 · ClinicalTrials.gov registry record · Phase 1
Prospective Exploratory Study of FAPi PET/CT in Prostate Cancer With Histopathology Validation
A Phase 1 study of Prostate Carcinoma and Recurrent Prostate Carcinoma, sponsored by Jonsson Comprehensive Cancer Center.
- Active
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT04457232: Active Phase 1 study of Prostate Carcinoma and Recurrent Prostate Carcinoma, sponsored by Jonsson Comprehensive Cancer Center.
NCT04457232 is a Phase 1 study of Prostate Carcinoma and Recurrent Prostate Carcinoma that is active but no longer recruiting, run by Jonsson Comprehensive Cancer Center. The registered enrollment target is 30 participants, below the 1,501-participant average among 59 other Prostate Carcinoma trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04457232, a Phase 1 study of Prostate Carcinoma and Recurrent Prostate Carcinoma, is active but no longer recruiting, sponsored by Jonsson Comprehensive Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
This exploratory study investigates how a new imaging technique called FAPI PET/CT can determine where and to which degree the FAPI tracer (68Ga-FAPi-46) accumulates in normal and cancer tissues in patients with prostate cancer. Because some cancers take up 68Ga-FAPi-46 it can be seen with PET. FAP stands for Fibroblast Activation Protein. FAP is produced by cells that surround tumors. The function of FAP is not well understood but imaging studies have shown that FAP can be detected with FAPI PET/CT. Imaging FAP with FAPI PET/CT may in the future provide additional information about various cancers including prostate cancer.
Primary Outcome
To quantify tumor tissue and normal background organs positron emission tomography (PET) tracer uptake by semi-quantitative analysis (unit/metrics = standardized uptake values \[SUV\], SUVmean and SUVmax.
Conditions Studied
Interventions
- PROCEDURE Computed Tomography
- PROCEDURE Positron Emission Tomography
- OTHER Gallium Ga 68 FAPi-46
Study Locations (1)
California
- UCLA / Jonsson Comprehensive Cancer Center - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2020-09-09 |
| Est. Completion | 2026-05-30 |
| Phase | Phase 1 |
What the registry record for NCT04457232 still lists
NCT04457232 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 1,501-participant average among 59 other Prostate Carcinoma trials with a reported enrollment target (98% lower).
The record links to 3 conditions, with Prostate Carcinoma appearing as the primary indexed condition, and to 3 interventions - of which Computed Tomography is the first listed.
NCT04457232 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04457232 about?
NCT04457232 is a clinical study titled "Prospective Exploratory Study of FAPi PET/CT in Prostate Cancer With Histopathology Validation". This exploratory study investigates how a new imaging technique called FAPI PET/CT can determine where and to which degree the FAPI tracer (68Ga-FAPi-46) accumulates in normal and cancer tissues in patients with prostate cancer. Because some cancers take up 68Ga-FAPi-46 it can be seen with PET. FAP ...
What is the current status of trial NCT04457232?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2020-09-09. Estimated completion is 2026-05-30.
What conditions does trial NCT04457232 study?
This clinical trial studies the following conditions: Prostate Carcinoma, Recurrent Prostate Carcinoma, Metastatic Malignant Neoplasm in the Prostate Gland.
What interventions are being tested in trial NCT04457232?
The interventions under investigation include: Computed Tomography (PROCEDURE), Positron Emission Tomography (PROCEDURE), Gallium Ga 68 FAPi-46 (OTHER).
Who is sponsoring clinical trial NCT04457232?
This trial is sponsored by Jonsson Comprehensive Cancer Center, which has 321 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04457232 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04457232's enrollment target sits among peer trials
30 48th of 59 higher than 9 of 59 other Prostate Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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