ACTIVE_NOT_RECRUITING

Experimental PET Imaging Scans Before Cancer Surgery to Study the Amount of PET Tracer Accumulated in Normal and Cancer Tissues

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

PET Biodistribution Study of 68Ga-PSMA-11 and 68Ga-FAPI-46 in Patients With Non-Prostate Cancers: An Exploratory Biodistribution Study With Histopathology Validation

Quick Facts

Study Start:2019-11-05
Study Completion:2031-10-17
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04147494

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients with the following cancer types:
  2. * Breast cancer
  3. * Colon cancer
  4. * Esophageal cancer
  5. * Gastric cancer
  6. * Head and Neck cancer
  7. * Lung cancer
  8. * Ovarian cancer
  9. * Pancreatic cancer
  10. * Renal cancer
  11. * Uterus cancer
  12. * Patients who are scheduled to undergo surgical resection of the primary tumor and/or metastasis
  13. * Patient can provide written informed consent
  14. * Patient is capable of complying with study procedures
  15. * Patient is able to remain still for duration of imaging procedure (up to one hour)
  1. * Patient is pregnant or nursing
  2. * Patients with any new cancer therapy between the baseline 18F-FDG PET/CT and the investigational FAPI PET/CT
  3. * Patient has underlying disease which, based on the judgment of the investigator, might interfere with the collection of high quality data

Contacts and Locations

Principal Investigator

Jeremie Calais, MD
PRINCIPAL_INVESTIGATOR
UCLA / Jonsson Comprehensive Cancer Center

Study Locations (Sites)

Ethan Lam
Los Angeles, California, 90095
United States

Collaborators and Investigators

Sponsor: Jonsson Comprehensive Cancer Center

  • Jeremie Calais, MD, PRINCIPAL_INVESTIGATOR, UCLA / Jonsson Comprehensive Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-11-05
Study Completion Date2031-10-17

Study Record Updates

Study Start Date2019-11-05
Study Completion Date2031-10-17

Terms related to this study

Additional Relevant MeSH Terms

  • Breast Carcinoma
  • Colon Carcinoma
  • Esophageal Carcinoma
  • Gastric Carcinoma
  • Head and Neck Carcinoma
  • Kidney Carcinoma
  • Lung Carcinoma
  • Ovarian Carcinoma
  • Pancreatic Carcinoma
  • Solid Neoplasm
  • Uterine Corpus Cancer