Experimental PET Imaging Scans Before Cancer Surgery to Study the Amount of PET Tracer Accumulated in Normal and Cancer Tissues
PET Biodistribution Study of 68Ga-PSMA-11 and 68Ga-FAPI-46 in Patients With Non-Prostate Cancers: An Exploratory Biodistribution Study With Histopathology Validation
2 other identifiers
interventional
29
1 country
1
Brief 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 the future provide additional information about various cancers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for early_phase_1
Started Nov 2019
Longer than P75 for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 24, 2019
CompletedFirst Posted
Study publicly available on registry
November 1, 2019
CompletedStudy Start
First participant enrolled
November 5, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 17, 2031
August 12, 2025
August 1, 2025
10.6 years
October 24, 2019
August 7, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
To define and document the biodistribution of gallium Ga 68 FAPi-46 (68Ga-FAPi-46) and gallium Ga 68-labeled PSMA-11 (68Ga-PSMA-11) in normal and cancer tissues of patients with various non-prostate malignancies
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).
60 minutes after tracer injection
Secondary Outcomes (2)
68Ga-FAPi-46 and 68Ga-PSMA-11 accumulation
From date of imaging to date of surgery (range 1-60 days)
evaluate the 68Ga-FAPI-46 biodistribution correlation with 18F-FDG biodistribution
up to 2 years
Other Outcomes (1)
Additional correlation of biodistribution of standard of care tracer
60 minutes after tracer injection
Study Arms (1)
Basic Science (68Ga-FAPi-46 PET/CT, 68Ga-PSMA-11 PET/CT)
EXPERIMENTALPatients receive 68Ga-FAPi-46 intravenously (IV), and then undergo PET/computed tomography (CT) over 20-90 minutes. On another day, patients receive 18F-FDG and then undergo PET/computed tomography (CT) according to standard of care procedures (if applicable). Patients may also receive 68Ga-PSMA-11 IV and undergo PET/CT scan over 20-50 minutes on a separate day (for volunteer patients only, PSMA PET/CT is optional and not required).
Interventions
Undergo PET/CT scan
Given IV
Given IV
Undergo PET/CT scan
Given IV
Eligibility Criteria
You may qualify if:
- Patients with the following cancer types:
- Breast cancer
- Colon cancer
- Esophageal cancer
- Gastric cancer
- Head and Neck cancer
- Lung cancer
- Ovarian cancer
- Pancreatic cancer
- Renal cancer
- Uterus cancer
- Patients who are scheduled to undergo surgical resection of the primary tumor and/or metastasis
- Patient can provide written informed consent
- Patient is capable of complying with study procedures
- Patient is able to remain still for duration of imaging procedure (up to one hour)
You may not qualify if:
- Patient is pregnant or nursing
- Patients with any new cancer therapy between the baseline 18F-FDG PET/CT and the investigational FAPI PET/CT
- Patient has underlying disease which, based on the judgment of the investigator, might interfere with the collection of high quality data
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ethan Lam
Los Angeles, California, 90095, United States
Related Publications (1)
Kunikowska J, Bizon M, Pelka K, Derlatka P, Olszewski M, Krolicki L. 68 Ga-Prostate-Specific Membrane Antigen PET/CT in Ovarian Tumors : Potential to Differentiate Benign and Malignant Tumors Before Surgery: A Preliminary Report. Clin Nucl Med. 2023 Feb 1;48(2):e60-e66. doi: 10.1097/RLU.0000000000004486. Epub 2022 Nov 18.
PMID: 36512649DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jeremie Calais, MD
UCLA / Jonsson Comprehensive Cancer Center
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 24, 2019
First Posted
November 1, 2019
Study Start
November 5, 2019
Primary Completion (Estimated)
June 1, 2030
Study Completion (Estimated)
October 17, 2031
Last Updated
August 12, 2025
Record last verified: 2025-08