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.
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
- Conditions the study is for
- Bladder Carcinoma, Cervical Carcinoma, Cholangiocarcinoma
- What is being tested?
- Computed Tomography, Gallium Ga 68 FAPi-46 and Positron Emission Tomography
- Type of treatment
- Injection or infusion, Surgery or procedure
- 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
- 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 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
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:
- 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:
- 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).
- Conditions
- Bladder Carcinoma, Cervical Carcinoma, Cholangiocarcinoma, Hematopoietic and Lymphoid Cell Neoplasm, Hepatocellular Carcinoma, Malignant Adrenal Gland Neoplasm
- 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 group | Role | What they receive |
|---|---|---|
| Basic science (68GA-FAPI-46 PET/CT) | Experimental | 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). 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.
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)
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
68Ga-FAPI-46 biodistribution correlation with 18F-FDG biodistribution
- 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.
- First posted7 Jul 2020
- Study start27 Aug 2020
- Primary completion24 Jun 2025
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
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
- 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
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PET Biodistribution Study of 68Ga-FAPI-46 in Patients With Different Malignancies: An Exploratory Biodistribution Study With Histopathology Validation
- ClinicalTrials.gov ID
- NCT04459273
- Acronym / sponsor ID
- FAPI PET RDRC / 20-000630
- Conditions
- Bladder Carcinoma, Cervical Carcinoma, Cholangiocarcinoma, Hematopoietic and Lymphoid Cell Neoplasm, Hepatocellular Carcinoma, Malignant Adrenal Gland Neoplasm
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 27 Aug 2020 (actual)
- Primary completion
- 24 Jun 2025 (actual)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 7 Jul 2020 (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 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.
Detailed description
PRIMARY OBJECTIVE:
- 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:
- 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).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Basic science (68GA-FAPI-46 PET/CT) | Experimental | Procedure: Computed Tomography, Drug: Gallium Ga 68 FAPi-46, Procedure: Positron Emission Tomography, Radiation: 18F-FDGPatients 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Patients with the following cancer types:
- 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)
Key exclusion criteria (3 listed)
- 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
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, Computerized Axial Tomography, Computerized TomographyUndergo PET/CT | Procedure or surgery | Basic science (68GA-FAPI-46 PET/CT) |
| Gallium Ga 68 FAPi-46Also: 68Ga-FAPi-46, Gallium-68-FAPi-46Given IV | Drug | Basic science (68GA-FAPI-46 PET/CT) |
| Positron Emission TomographyAlso: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography ScanUndergo PET/CT | Procedure or surgery | Basic science (68GA-FAPI-46 PET/CT) |
| 18F-FDGAlso: 18F-fluorodeoxyglucoseGiven IV | Radiation | Basic science (68GA-FAPI-46 PET/CT) |
Primary outcome
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).
2 secondary outcomes
68Ga-FAPi-46 accumulation observed by positron emission tomography (PET)/computed tomography (CT)
Time frame: Up to year 2
68Ga-FAPI-46 biodistribution correlation with 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 5 Feb 2026.
Related trials for Bladder Carcinoma
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
RecruitingObservational study
Increasing Pre-Surgical Identification of Muscle Invasive Tumor Evaluations Prior to Planned Cystectomy (INSITE)
Urothelial Carcinoma, Muscle Invasive Bladder Urothelial Carcinoma
Active, not recruitingPhase 3
Comparing the New Anti-cancer Drug Eribulin With Chemotherapy Against the Usual Chemotherapy Alone in Metastatic Urothelial Cancer
Metastatic Bladder Urothelial Carcinoma, Metastatic Urothelial Carcinoma
RecruitingPhase 2
A Study to Find Out if Enfortumab Vedotin Given With Pembrolizumab Helps People With Muscle-invasive Bladder Cancer Keep Their Bladder
Muscle-invasive Bladder Cancer
RecruitingObservational study
Evaluation for NCI Surgery Branch Clinical Research Protocols
Synovial Cell Cancer, Melanoma
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, 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.
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 20 inclusion and 3 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 5 Feb 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 68Ga-FAPi-46 in normal and cancer tissues (time frame: At 20-90 minutes after injection]). 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 5 Feb 2026.