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NCT04147494Active, not recruitingEarly phase 1

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

Source: ClinicalTrials.gov · Last updated 21 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Early phase 1
Study type
Interventional
Enrollment
29 (actual)
First submitted
24 Oct 2019
Start date
5 Nov 2019
Primary completion date
1 Jun 2030
Lead sponsor
Jonsson Comprehensive Cancer Center
NCT number
NCT04147494

What you commit to

  • Study type: Interventional · Early phase 1
  • Participants enrolled: 29
  • From 5 Nov 2019 to the primary completion date, 1 Jun 2030
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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

Other

  • Patient is pregnant or nursing

Who the study is looking for

  • 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)

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Ethan Lam
Coordinator of this site? Confirm its status
Los AngelesUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.