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.
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
- Conditions the study is for
- Anal Carcinoma, Bladder Carcinoma, Breast Carcinoma
- What is being tested?
- Computed Tomography, Fludeoxyglucose F-18 and Gallium Ga 68 FAPi-46
- Type of treatment
- Injection or infusion, Surgery or procedure
- 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
- Are there results?
- Not yet: the study is under way
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
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:
- 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:
- 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.
- Conditions
- Anal Carcinoma, Bladder Carcinoma, Breast Carcinoma, Cervical Carcinoma, Cholangiocarcinoma, Colorectal Carcinoma
- 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 group | Role | What they receive |
|---|---|---|
| Diagnostic (68Ga-FAPi-46 PET/CT) | Experimental | Patients 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.
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)
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.
- First posted12 Aug 2025
- Study start1 Aug 2025
- Primary completion23 Jun 2026
- Study completion7 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anal CarcinomaStudies of the same condition, open and under way.
- More trials run by Jonsson Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeremie Calais, Principal investigator, UCLA / Jonsson Comprehensive Cancer Center
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
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PET Imaging Study of 68Ga-FAPI-46 Biodistribution in Cancer Patients
- ClinicalTrials.gov ID
- NCT07118176
- Acronym / sponsor ID
- 25-0201
- Conditions
- Anal Carcinoma, Bladder Carcinoma, Breast Carcinoma, Cervical Carcinoma, Cholangiocarcinoma, Colorectal Carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 23 Jun 2026 (actual)
- Study completion
- 7 Sep 2027 (estimated)
- First posted
- 12 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVE:
- 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:
- 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (68Ga-FAPi-46 PET/CT) | Experimental | Procedure: Computed Tomography, Other: Fludeoxyglucose F-18, Radiation: Gallium Ga 68 FAPi-46, Procedure: Positron Emission TomographyPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (37 listed)
- Patients with the following suspected or diagnosed cancer types:
- 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)
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computed TomographyAlso: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial TomographyUndergo PET/CT | Procedure or surgery | Diagnostic (68Ga-FAPi-46 PET/CT) |
| Fludeoxyglucose F-18Also: 18FDG, FDG, Fludeoxyglucose (18F), fludeoxyglucose F 18Given IV | Other | Diagnostic (68Ga-FAPi-46 PET/CT) |
| Gallium Ga 68 FAPi-46Also: (68GA)Ga-FAPI-46, 68Ga-FAPi-46, FAPI-46 GA-68, Gallium-68-FAPI-46Given IV | Radiation | Diagnostic (68Ga-FAPi-46 PET/CT) |
| Positron Emission TomographyAlso: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)Undergo PET/CT | Procedure or surgery | Diagnostic (68Ga-FAPi-46 PET/CT) |
Primary outcome
Biodistribution of gallium Ga 68 FAPi-46 (68Ga-FAPi-46)
Time frame: Up to 2 years
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.
1 secondary outcome
Fludeoxyglucose F-18 (18F-FDG) biodistribution
Time frame: Up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeremie Calais principal investigator
UCLA / Jonsson Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 37 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biodistribution of gallium Ga 68 FAPi-46 (68Ga-FAPi-46) (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.