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Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers (FAPI PET RDRC)

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ClinicalTrials.gov Identifier: NCT04459273
Recruitment Status : Recruiting
First Posted : July 7, 2020
Last Update Posted : September 26, 2022
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center

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.

Condition or disease Intervention/treatment Phase
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 Procedure: Computed Tomography Drug: Gallium Ga 68 FAPi-46 Procedure: Positron Emission Tomography Phase 1

Detailed Description:


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 correlation of 68Ga-FAPI-46 biodistribution with 18F-fluodeoxyglucose (FDG), 68Ga-DOTATATE, or 18F-DOPA (FDOPA), depending on the specific indication.


Patients receive 68Ga-FAPi-46 intravenously (IV) then 20-90 minutes later undergo PET/computed tomography (CT).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: PET Biodistribution Study of 68Ga-FAPI-46 in Patients With Different Malignancies: An Exploratory Biodistribution Study With Histopathology Validation
Actual Study Start Date : August 27, 2020
Estimated Primary Completion Date : July 1, 2023
Estimated Study Completion Date : July 1, 2024

Arm Intervention/treatment
Experimental: Basic science (68GA-FAPI-46 PET/CT)
Patients receive 68Ga-FAPi-46 IV then 20-90 minutes later undergo PET/CT.
Procedure: Computed Tomography
Undergo PET/CT
Other Names:
  • CAT
  • CAT Scan
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT
  • CT Scan
  • tomography

Drug: Gallium Ga 68 FAPi-46
Given IV
Other Names:
  • 68Ga-FAPi-46
  • Gallium-68-FAPi-46

Procedure: Positron Emission Tomography
Undergo PET/CT
Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • PET Scan
  • Positron Emission Tomography Scan
  • Positron-Emission Tomography
  • proton magnetic resonance spectroscopic imaging

Primary Outcome Measures :
  1. Biodistribution of gallium 68Ga-FAPi-46 in normal and cancer tissues [ Time Frame: At 20-90 minutes after injection] ]
    Will be quantified by mean and maximum standardized uptake values (SUVmean and SUVmax).

Secondary Outcome Measures :
  1. 68Ga-FAPi-46 accumulation observed by positron emission tomography (PET)/computed tomography (CT) [ Time Frame: Up to year 2 ]
    Will be correlated with FAP expression in surgically removed or biopsy derived tumor tissue.

Other Outcome Measures:
  1. To assess the 68Ga-FAPI-46 biodistribution correlation with other PET tracers [ Time Frame: 60 minutes after tracer injection ]
    The other PET tracer biodistribution will be described by mean and maximum standardized uptake values (SUVmean and SUVmax). The SUV of FAPI PET and the other PET tracers will be tested for correlation.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  • Patients who underwent a staging PET/CT scan within 3 months of enrollment (with any PET tracer related to the indication including FDG, DOTATATE, FDOPA)
  • Patients who are scheduled to undergo surgical resection or tissue biopsy of the primary tumor and/or metastasis
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04459273

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Contact: Andrea Limon 310-206-7372 AndreaLimon@mednet.ucla.edu
Contact: Rejah Marie Alano 310-206-7372 RMAlano@mednet.ucla.edu

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United States, California
UCLA / Jonsson Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90095
Contact: Andrea Limon    310-206-7372    AndreaLimon@mednet.ucla.edu   
Contact: Rejah Marie Alano    310-206-7372    RMAlano@mednet.ucla.edu   
Principal Investigator: Jeremie Calais         
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
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Principal Investigator: Jeremie Calais UCLA / Jonsson Comprehensive Cancer Center
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Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT04459273    
Other Study ID Numbers: 20-000630
NCI-2020-03766 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: July 7, 2020    Key Record Dates
Last Update Posted: September 26, 2022
Last Verified: July 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Brain Neoplasms
Urinary Bladder Neoplasms
Neuroendocrine Tumors
Thyroid Neoplasms
Skin Neoplasms
Testicular Neoplasms
Pleural Neoplasms
Adrenal Gland Neoplasms
Thymus Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms by Site
Central Nervous System Neoplasms
Nervous System Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Urologic Neoplasms
Urogenital Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Endocrine Gland Neoplasms
Head and Neck Neoplasms