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

  • End date
    Jul 1, 2024
  • participants needed
  • sponsor
    Jonsson Comprehensive Cancer Center
Updated on 13 October 2022
ct scan
hematologic malignancy
pet scan
positron emission tomography
thymus cancer
bladder cancer
pet/ct scan
bladder tumor


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 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).

Condition 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
Treatment computed tomography, positron emission tomography, Gallium Ga 68 FAPi-46
Clinical Study IdentifierNCT04459273
SponsorJonsson Comprehensive Cancer Center
Last Modified on13 October 2022


Yes No Not Sure

Inclusion Criteria

Patients with the following cancer types
Brain cancer
Bladder cancer
Urothelial cancer
Testicular cancer
Skin cancer
Thyroid cancer
Hepatocellular carcinoma
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
Patients who are scheduled to undergo surgical resection or tissue biopsy of the primary tumor and/or metastasis
PET tracer related to the indication including FDG, DOTATATE, FDOPA)
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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact


Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note