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Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers

About

Brief Summary

This exploratory study investigates how an imaging technique called 68Ga-FAPi-46 PET/CT can determine where and to which degree the FAPI tracer (68Ga-FAPi-46) accumulates in normal and cancer tissues in patients with 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 (cancer associated fibroblasts). 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.

Primary Purpose
Basic science
Study Type
Interventional
Phase
Phase 1

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

Inclusion Criteria:

  • Patients with the following cancer types:
    • Brain cancer
    • Bladder cancer
    • Urothelial cancer
    • Testicular cancer
    • Skin cancer
    • Thyroid cancer
    • Hepatocellular carcinoma
    • Cholangiocarcinoma
    • Thymus cancer
    • Pleural cancer
    • Cervical cancer
    • Adrenal cancer
    • Neuroendocrine tumors
    • Hematologic cancer
    • Cancer of Unkown Primary
  • Patients who are scheduled to undergo surgical resection or tissue biopsy of the primary tumor and/or metastasis
  • Patients are ≥ 18 years old at the time of the radiotracer administration.
  • Patient can provide written informed consent
  • Patient is able to remain still for duration of imaging procedure (up to one hour)

Exclusion Criteria:

  • Patient is pregnant or nursing
  • Patients with any new cancer therapy between the baseline 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

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Study Stats
Protocol No.
20-000630
Category
Bladder Cancer
Brain Cancer
Breast Cancer
Cervical Cancer
Colorectal Cancer
Esophageal Cancer
Gallbladder Cancer
Head and Neck Cancer
Kidney Cancer
Leukemia
Liver Cancer
Lung Cancer
Lymphoma
Melanoma (Skin Cancer)
Multiple Myeloma
Non-Melanoma Skin Cancer
Other Cancer
Ovarian Cancer
Pancreatic Cancer
Prostate Cancer
Sarcoma
Stomach Cancer
Uterine/Endometrial Cancer
Principal Investigator
Contact
JEREMIE CALAIS
Location
  • UCLA Westwood
For Providers
NCT No.
NCT04459273
For detailed technical eligibility, visit ClinicalTrials.gov.