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NCT04147494 · ClinicalTrials.gov registry record · Early Phase 1
Experimental PET Imaging Scans Before Cancer Surgery to Study the Amount of PET Tracer Accumulated in Normal and Cancer Tissues
A Early Phase 1 study of Breast Carcinoma and Lung Carcinoma, sponsored by Jonsson Comprehensive Cancer Center.
- Active
- Registry status
- Early Phase 1
- Development phase
- 29
- Enrollment target
- 1
- Study location
NCT04147494: Active Early Phase 1 study of Breast Carcinoma and Lung Carcinoma, sponsored by Jonsson Comprehensive Cancer Center.
NCT04147494 is a Early Phase 1 study of Breast Carcinoma and Lung Carcinoma that is active but no longer recruiting, run by Jonsson Comprehensive Cancer Center. The registered enrollment target is 29 participants, below the 770-participant average among 106 other Breast Carcinoma trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04147494, a Early Phase 1 study of Breast Carcinoma and Lung Carcinoma, is active but no longer recruiting, sponsored by Jonsson Comprehensive Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 29 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I trial studies a new imaging technique called FAPi PET/CT to determine where and to which degree the FAPI tracer (68Ga-FAPi-46) accumulate in normal and cancer tissues in patients with non-prostate cancer. The research team also want to know whether what they see on PET/CT images represents the tumor tissue being excised from the patient's body. The research team is also interested to investigate another new imaging technique called PSMA PET/CT. Participants will be invited to undergo another PET/CT scan, with the PSMA tracer (68Ga-PSMA-11). This is not required but just an option for volunteer patients. Patients who have not received an 18F-FDG PET/CT within one month of enrollment will also undergo an FDG PET/CT scan. The PET/CT scanner combines the PET and the CT scanners into a single device. This device combines the anatomic (body structure) information provided by the CT scan with the metabolic information obtained from the PET scan. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of, in the case of this research, 68Ga-PSMA-11 and 68Ga-FAPi, and 18F-FDG (if applicable). Because some cancers take up 68Ga-PSMA-11 and/or 68Ga-FAPi it can be seen with PET. CT utilizes x-rays that traverse the body from the outside. CT images provide an exact outline of organs where it occurs in patient's body. 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. PSMA stands for Prostate Specific Membrane Antigen. This name is incorrect as PSMA is also found in many other cancers. The function of PSMA is not well understood but imaging studies have shown that PSMA can be detected with PET in many non-prostate cancers. Imaging FAP with PET/CT may in
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)). The 68Ga-PSMA-11 and 68Ga-FAPI-46 tracer biodistribution will be described by mean and maximum standardized uptake values (SUVmean and SUVmax).
Conditions Studied
Interventions
- PROCEDURE Computed Tomography
- PROCEDURE Positron Emission Tomography
- RADIATION Gallium Ga 68 FAPi-46
- RADIATION Gallium Ga 68-labeled PSMA-11
- RADIATION 18F-FDG
Study Locations (1)
California
- Ethan Lam - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2019-11-05 |
| Est. Completion | 2031-10-17 |
| Phase | Early Phase 1 |
What the registry record for NCT04147494 still lists
NCT04147494 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 770-participant average among 106 other Breast Carcinoma trials with a reported enrollment target (96% lower).
The record links to 10 conditions, with Breast Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Computed Tomography is the first listed.
NCT04147494 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04147494 about?
NCT04147494 is a clinical study titled "Experimental PET Imaging Scans Before Cancer Surgery to Study the Amount of PET Tracer Accumulated in Normal and Cancer Tissues". This phase I trial studies a new imaging technique called FAPi PET/CT to determine where and to which degree the FAPI tracer (68Ga-FAPi-46) accumulate in normal and cancer tissues in patients with non-prostate cancer. The research team also want to know whether what they see on PET/CT images represe...
What is the current status of trial NCT04147494?
This trial is currently active not recruiting. It is a Early Phase 1 study. The enrollment target is 29 participants. The study started on 2019-11-05. Estimated completion is 2031-10-17.
What conditions does trial NCT04147494 study?
This clinical trial studies the following conditions: Breast Carcinoma, Lung Carcinoma, Ovarian Carcinoma, Head and Neck Carcinoma, Pancreatic Carcinoma.
What interventions are being tested in trial NCT04147494?
The interventions under investigation include: Computed Tomography (PROCEDURE), Positron Emission Tomography (PROCEDURE), Gallium Ga 68 FAPi-46 (RADIATION), Gallium Ga 68-labeled PSMA-11 (RADIATION), 18F-FDG (RADIATION).
Who is sponsoring clinical trial NCT04147494?
This trial is sponsored by Jonsson Comprehensive Cancer Center, which has 321 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04147494 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
Similar trials for Breast Carcinoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04147494's enrollment target sits among peer trials
29 93rd of 106 higher than 14 of 106 other Breast Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast 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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