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Bladder CarcinomaPhase 1FAPI PET RDRCNCT04459273

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

A Phase 1 study testing Computed Tomography, Gallium Ga 68 FAPi-46 and Positron Emission Tomography in people with Bladder Carcinoma and Cervical Carcinoma, run by Jonsson Comprehensive Cancer Center at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Computed Tomography, Gallium Ga 68 FAPi-46 and Positron Emission Tomography
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
1 siteUnited States
Study dates
27 Aug 2020to 1 Jul 2027
Phase
Phase 1

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with the following cancer types:
  • Brain cancer
  • Bladder cancer
  • Urothelial cancer
  • Testicular cancer
  • Skin cancer
Show all 20Show fewer
  • 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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UCLA / Jonsson Comprehensive Cancer Center

    Los Angeles, California, 90095

Other trials in United States

About this study

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

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.

Read the detailed description

PRIMARY OBJECTIVE:

  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.

SECONDARY OBJECTIVES:

  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-)

EXPERIMENTAL OBJECTIVE:

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

OUTLINE:

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).

Being tested
Computed Tomography, Gallium Ga 68 FAPi-46, Positron Emission Tomography, 18F-FDG
Medical subject headings
Urinary Bladder Neoplasms, Uterine Cervical Neoplasms, Cholangiocarcinoma, Hematologic Neoplasms, Carcinoma, Hepatocellular, Adrenal Gland Neoplasms, Brain Neoplasms, Skin Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography

    Undergo PET/CT

  • Gallium Ga 68 FAPi-46Drug

    Also called 68Ga-FAPi-46, Gallium-68-FAPi-46

    Given IV

  • Positron Emission TomographyProcedure or surgery

    Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan

    Undergo PET/CT

  • 18F-FDGRadiation

    Also called 18F-fluorodeoxyglucose

    Given IV

Study groups in NCT04459273
Study groupRoleWhat they receive
Basic science (68GA-FAPI-46 PET/CT)ExperimentalPatients 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).
Receives: Procedure: Computed Tomography; Drug: Gallium Ga 68 FAPi-46; Procedure: Positron Emission Tomography; Radiation: 18F-FDG

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Biodistribution of gallium 68Ga-FAPi-46 in normal and cancer tissues

    Will be quantified by mean and maximum standardized uptake values (SUVmean and SUVmax).

    Measured: At 20-90 minutes after injection]

Secondary outcomes (2)

  1. 68Ga-FAPi-46 accumulation observed by positron emission tomography (PET)/computed tomography (CT)

    Will be correlated with FAP expression in surgically removed or biopsy derived tumor tissue.

    Measured: Up to year 2

  2. 68Ga-FAPI-46 biodistribution correlation with 18F-FDG biodistribution

    1. 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-)

    Measured: up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jul 2020
  2. Study start27 Aug 2020
  3. Primary completion24 Jun 2025
  4. Study completion1 Jul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04459273
Sponsor's protocol ID
20-000630
Other IDs
NCI-2020-03766
Acronym
FAPI PET RDRC
Status last verified
Aug 2025
First submitted
1 Jul 2020
Last updated
5 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

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