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Brief Title: FAPi PET/CT With Histopathology Validation in Patients With Various Cancers

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


  • Org Study ID: 20-000630
  • Secondary ID: N/A
  • NCT ID: NCT04459273
  • Sponsor: Jonsson Comprehensive Cancer Center


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.



I. 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.


I. 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).

  • Overall Status
  • Start Date
    August 27, 2020
  • Phase
    Phase 1
  • Study Type


Primary Outcome 1 - Measure:

Primary Outcome 1 - Timeframe: N/A


  • 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


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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No


Name: Jeremie Calais

Role: Principal Investigator

Affiliation: UCLA / Jonsson Comprehensive Cancer Center

Overall Contact

Name: Ethan Lam, Stephanie Lira

Phone: 310-206-7372, 310-206-7372



Facility Status Contact
Facility: UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California 90095
United States
Status: Recruiting Contact: Contact
Ethan Lam

Stephanie Lira

Principal Investigator
Jeremie Calais