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Anal CarcinomaPhase 1NCT07118176

Determining the Biodistribution of an Imaging Tracer (68Ga-FAPi-46) in Patients With Solid Tumors or Hematologic Cancers

A Phase 1 study testing Computed Tomography, Fludeoxyglucose F-18 and Gallium Ga 68 FAPi-46 in people with Anal Carcinoma and Bladder 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 phase I trial is evaluating a new imaging tracer (68Ga-FAPi-46) with positron emission tomography (PET)/computed tomography (CT) to determine where and to which degree the tracer (68Ga-FAPi-46) accumulates in normal and cancer tissues (the biodistribution) in patients with solid tumors or hematologic (blood)… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Computed Tomography, Fludeoxyglucose F-18 and Gallium Ga 68 FAPi-46
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
1 Aug 2025to 7 Sep 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 suspected or diagnosed cancer types:
  • Adrenal cancer
  • Anal cancer
  • Bladder cancer
  • Brain cancer
  • Breast cancer
Show all 37Show fewer
  • Cancer of unknown primary (CUP)
  • Cervical cancer
  • Cholangiocarcinoma
  • Colorectal cancer
  • Esophageal cancer
  • Gastric cancer
  • Head and neck cancer
  • Hematologic cancer
  • Hepatocellular carcinoma
  • Lung cancer
  • Medullary thyroid cancer
  • Neuroendocrine neoplasias
  • Ovarian cancer
  • Pancreatic cancer
  • Penile cancer
  • Peritoneal cancer
  • Pleural cancer
  • Prostate cancer
  • Sarcoma
  • Salivary gland cancer
  • Solitary fibrous tumor
  • Skin cancer
  • Testicular cancer
  • Thymus cancer
  • Thyroid cancer
  • Urothelial cancer
  • Uterus cancer
  • Vaginal cancer
  • 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
  • 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 Imaging Study of 68Ga-FAPI-46 Biodistribution in Cancer Patients

This phase I trial is evaluating a new imaging tracer (68Ga-FAPi-46) with positron emission tomography (PET)/computed tomography (CT) to determine where and to which degree the tracer (68Ga-FAPi-46) accumulates in normal and cancer tissues (the biodistribution) in patients with solid tumors or hematologic (blood) cancers. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer, in the case of this research, 68Ga-FAPi-46. Because some cancers take up 68Ga-FAPi-46, it can be seen with PET. CT utilizes x-rays that traverse the body from the outside. CT images provide an exact outline of organs and potential inflammatory tissue where it occurs in a patient's body. Combining a PET scan with a CT scan can help make the image easier to interpret. PET/CT scans are hybrid scanners that combine both modalities into a single scan during the same examination.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To define the biodistribution of gallium Ga 68 FAPi-46 (68Ga-FAPi-46) in normal and cancer tissues of patients with various malignancies measured by standardized uptake values (SUV).

SECONDARY OBJECTIVE:

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

OUTLINE:

Patients receive 68Ga-FAPi-46 intravenously (IV) and then, 20-90 minutes later, undergo PET/CT over 20-50 minutes. Patients may undergo optional 18F-FDG PET/CT on study.

Being tested
Computed Tomography, Fludeoxyglucose F-18, Gallium Ga 68 FAPi-46, Positron Emission Tomography
Medical subject headings
Anus Neoplasms, Urinary Bladder Neoplasms, Breast Neoplasms, Uterine Cervical Neoplasms, Cholangiocarcinoma, Colorectal Neoplasms, Esophageal Neoplasms, Stomach 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, Computed Axial Tomography, Computerized Axial Tomography

    Undergo PET/CT

  • Fludeoxyglucose F-18Other

    Also called 18FDG, FDG, Fludeoxyglucose (18F), fludeoxyglucose F 18

    Given IV

  • Gallium Ga 68 FAPi-46Radiation

    Also called (68GA)Ga-FAPI-46, 68Ga-FAPi-46, FAPI-46 GA-68, Gallium-68-FAPI-46

    Given IV

  • Positron Emission TomographyProcedure or surgery

    Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)

    Undergo PET/CT

Study groups in NCT07118176
Study groupRoleWhat they receive
Diagnostic (68Ga-FAPi-46 PET/CT)ExperimentalPatients receive 68Ga-FAPi-46 IV and then, 20-90 minutes later, undergo PET/CT over 20-50 minutes. Patients may undergo optional 18F-FDG PET/CT on study.
Receives: Procedure: Computed Tomography; Other: Fludeoxyglucose F-18; Radiation: Gallium Ga 68 FAPi-46; Procedure: Positron Emission Tomography

What is being measured

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

  1. Biodistribution of gallium Ga 68 FAPi-46 (68Ga-FAPi-46)

    Will be evaluated in normal and cancer tissues by standardized uptake values to determine where and to which degree 68Ga-FAPi-46 accumulates in normal and cancer tissues.

    Measured: Up to 2 years

Secondary outcomes (1)

  1. Fludeoxyglucose F-18 (18F-FDG) biodistribution

    Will assess the correlation between 68Ga-FAPi-46 biodistribution and 18F-FDG biodistribution and define the frequency of the following phenotypes: 68Ga-FAPi-46 (FAP)+/fludeoxyglucose F-18 (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 posted12 Aug 2025
  2. Study start1 Aug 2025
  3. Primary completion23 Jun 2026
  4. Study completion7 Sep 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
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07118176
Sponsor's protocol ID
25-0201
Other IDs
NCI-2025-04961
Status last verified
Jun 2026
First submitted
5 Aug 2025
Last updated
20 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

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