for people ages 18 years and up (full criteria)
study started
completion around
Principal Investigator
by Jeremie Calais (ucla)
Headshot of Jeremie Calais
Jeremie Calais



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.

Official Title

PET Biodistribution Study of 68Ga-FAPI-46 in Patients With Different Malignancies: An Exploratory Biodistribution Study With Histopathology Validation



  1. To define the biodistribution of gallium Ga 68 fibroblast activation protein inhibitor (FAPi)-46 (68Ga-FAPi-46) in normal and cancer tissues of patients with various malignancies.


  1. To evaluate the degree of 68Ga-FAPi-46 accumulation observed by positron emission tomography (PET) imaging as opposed to the amount of FAP in excised cancer tissue.

II. To assess the 68Ga-FAPI-46 biodistribution correlation with 18F-FDG biodistribution and to define the frequency of the following phenotypes (FAP+/ FDG+, FAP-/ FDG+, FAP+/ FDG-, FAP-/ FDG-)


To assess the correlation of 68Ga-FAPI-46 biodistribution with 68Ga-DOTATATE or 18F-DOPA (FDOPA), depending on the specific indication in patients who had them available


Patients 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).


Bladder Carcinoma, Cervical Carcinoma, Cholangiocarcinoma, Hematopoietic and Lymphoid Cell Neoplasm, Hepatocellular Carcinoma, Malignant Adrenal Gland Neoplasm, Malignant Brain Neoplasm, Malignant Pleural Neoplasm, Malignant Skin Neoplasm, Malignant Solid Neoplasm, Malignant Testicular Neoplasm, Malignant Thymus Neoplasm, Neuroendocrine Neoplasm, Thyroid Gland Carcinoma, Urothelial Carcinoma, Cancer of Unknown Primary Site, Carcinoma, Neoplasms, Brain Neoplasms, Urinary Bladder Neoplasms, Neuroendocrine Tumors, Thyroid Neoplasms, Skin Neoplasms, Testicular Neoplasms, Pleural Neoplasms, Unknown Primary Neoplasms, Thymus Neoplasms, Adrenal Gland Neoplasms, Fluorodeoxyglucose F18, FAPI-46, Computed Tomography, Gallium Ga 68 FAPi-46, Positron Emission Tomography, 18F-FDG, Basic science (68GA-FAPI-46 PET/CT)


You can join if…

Open to people ages 18 years and up

  • Patients with the following cancer types:
  • 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)

You CAN'T join if...

  • 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


  • UCLA / Jonsson Comprehensive Cancer Center accepting new patients
    Los Angeles California 90095 United States

Lead Scientist at University of California Health

  • Jeremie Calais (ucla)
    Nuclear medicine physician specialized in cancer imaging and theranostics. Associate Professor, Department of Molecular and Medical Pharmacology at UCLA Director, Theranostics Program, Ahmanson Translational Theranostics Division at UCLA Faculty Member of the Jonsson Comprehensive Cancer Center at UCLA. Faculty Member of the Institute of Urologic Oncology at UCLA.


accepting new patients
Start Date
Completion Date
Jonsson Comprehensive Cancer Center
Phase 1 research study
Study Type
Expecting 30 study participants
Last Updated