Bladder CancerEarly Phase 1NCT04018053
18Fluorine-Fluciclovine PET/CT for Staging Muscle Invasive Bladder Cancer Preceding Radical Cystectomy
A Early Phase 1 study testing 18F-fluciclovine and PET/CT in people with Bladder Cancer and Urothelial Carcinoma, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
This research study is studying a positron emission tomography (PET) agent called 18F-fluciclovine to evaluate how well 18F-fluciclovine-PET scans determine the extent of muscle invasive bladder cancer (as compared to regular CT and MRI imaging) and whether 18F-fluciclovine-PET scans can provide information about the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer, Urothelial Carcinoma
- What is being tested?
- 18F-fluciclovine and PET/CT
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Feb 2020to 25 Sep 2025
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Participants must have histologically or cytologically confirmed urothelial carcinoma of the bladder.
- Participants must have cT2-T4N0 disease at the time of the study, as defined by conventional CT or MRI imaging. Patients must have no definite evidence of locoregional or distant metastatic disease at the time of study eligibility, as defined by conventional imaging.
- Radical cystectomy must be planned for the patient after the planned 18F-fluciclovine-PET/CT.
- Patients may or may not have had prior neoadjuvant therapy prior to this study.
- Age ≥18 years. Since no dosing or adverse event data are currently available on the use of 18F-fluciclovine in participants <18 years of age, and the majority of bladder cancer occur in the adult population [42], children are excluded from this study but will be eligible for future pediatric trials.
- ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A)
Show all 9Show fewer
- Ability and willingness to comply with the study procedures.
- The effects of 18F-fluciclovine on the developing human fetus are unknown. For this reason and because radiopharmaceuticals may be teratogenic, women of childbearing potential and men must agree to use adequate contraception (barrier method of birth control; abstinence) prior to study entry and for 24 hours after the PET/CT scan is completed. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- Ability to understand and the willingness to sign a written informed consent document
Who cannot join
- Participants with other known malignancies that has required treatment in the past 3 years.
- Pregnant women are excluded from this study because 18F-fluciclovine is a radiopharmaceutical with the potential for teratogenic effects. Because of the radiation exposure to a nursing infant from 18F-fluciclovine, women who are breastfeeding are also excluded from this study.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to 18F-fluciclovine.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Contraindications for PET/CT including:
- Severe claustrophobia
- Any past or current condition that in the opinion of the study investigators would confound the results of the study or pose additional risk to the patient by their participation in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
Official title: A Pilot Study of 18Fluorine-Fluciclovine Positron Emission Tomography/Computed Tomography for Staging Muscle Invasive Bladder Cancer Preceding Radical Cystectomy
This research study is studying a positron emission tomography (PET) agent called 18F-fluciclovine to evaluate how well 18F-fluciclovine-PET scans determine the extent of muscle invasive bladder cancer (as compared to regular CT and MRI imaging) and whether 18F-fluciclovine-PET scans can provide information about the pathologic grade of the tumor.
Read the detailed description
This research study is a pilot study, which is the first-time investigators are examining this study imaging agent, 18F-fluciclovine, for use in imaging bladder cancer.
Staging of muscle invasive bladder cancer is currently done using computed tomography (CT) and/or magnetic resonance imaging (MRI). Both CT and MRI are useful to determine the extent of bladder cancer, but some studies show that up to 40% of patients with negative CT or MRI scans for disease outside the bladder are found to have disease outside the bladder (in lymph nodes near the bladder) at the time of surgery.
Given the limitations of the imaging exams currently used for staging bladder cancer, new techniques and imaging agents that can better identify metastatic lesions, especially within the pelvis, are desired and would be very useful.
18F-fluciclovine is a new radiotracer that was recently approved to evaluate lesions in recurrent prostate cancer (but not for bladder cancer). This radiotracer targets amino-acid receptors, which are overexpressed in multiple cancers. Studies have shown that 18F-fluciclovine PET/CT can visualize other types of cancers, such as breast cancer. A major advantage of 18F-fluciclovine is that it does not get into the bladder during the time of imaging. This may make it easier to see disease in the pelvis that is outside the bladder.
The purpose of this study to determine whether 18F-fluciclovine PET/CT can better stage muscle invasive bladder cancer compared to conventional CT or MRI. A secondary aim of this study is to determine whether 18F-fluciclovine PET/CT can reveal the pathologic grade of the bladder cancer, which is only determined from pathology specimens obtained at surgery.
- Conditions
- Bladder Cancer, Urothelial Carcinoma
- Being tested
- 18F-fluciclovine, PET/CT
- Keywords
- Bladder cancer, urothelial carcinoma, cystectomy
- Medical subject headings
- Urinary Bladder Neoplasms, Carcinoma, Transitional Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-fluciclovineDrug
Also called Axumin
18F-fluciclovine is a new radiotracer. This radiotracer targets amino-acid transporters, which are overexpressed in multiple cancers.
PET/CTDevice
Positron emission tomography/computed tomography (PET/CT) uses small amounts of radioactive materials called radiotracers, a special camera and a computer to help evaluate organ and tissue functions.
| Study group | Role | What they receive |
|---|---|---|
| 18F-fluciclovine | Experimental | * 18F-fluciclovine will be administered via slow push over 10 seconds through a peripheral intravenous line
* Immediately after the injection of the radiopharmaceutical, dynamic PET/CT images of the pelvis will be obtained for 15 minutes
* Subsequently, PET/CT images will be obtained from the pelvis to the base of skull. Receives: Drug: 18F-fluciclovine; Device: PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement Rate of Metastatic Disease Status Between 18F-fluciclovine-PET/CT and Histopathology From Radical Cystectomy
Lymph nodes will be classified as positive or negative for metastatic disease on 18F-fluciclovine PET/CT and compared to pathologic stage as determined from surgery.
Measured: Single session from 18F-fluciclovine PET/CT scan and single session results from pathology at radical cystectomy, up to 24 hours.
Secondary outcomes (2)
Amount of 18F-fluciclovine Accumulation in the Primary Bladder Tumor on PET
18F-fluciclovine Standard Uptake Value in primary bladder tumor as a measure of 18F-fluciclovine accumulation
Measured: Time of 18F-fluciclovine PET/CT scan visit
Number of Participants With Suspected Distant Metastatic Disease by 18F-fluciclovine-PET/CT
Visualization of distant metastases on 18F-fluciclovine-PET/CT will be binary-categorized as present/absent. We will compute sensitivity to compare 18F-fluciclovine-PET/CT with standard imaging modalities for distant metastases. The number of distant metastases will be descriptively shown by imaging modalities.
Measured: single session at time of 18F-fluciclovine PET/CT scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2019
- Study start26 Feb 2020
- Primary completion30 Jun 2024
- Study completion25 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Blue Earth Diagnostics
- Responsible party
- Principal investigator, Heather A. Jacene, MD, Brigham and Women's Hospital
- Investigators
- Heather Jacene, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04018053
- Sponsor's protocol ID
- 19-208
- Status last verified
- May 2026
- First submitted
- 10 Jul 2019
- Last updated
- 24 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research
Publications
Ng TSC, Liu M, Robertson M, Konik A, Cheng SC, Bakht MK, Harrington K, Wolanski A, Gilbert L, Preston M, Mossanen M, Beltran H, Hirsch MS, Sonpavde G, Jacene HA. A pilot study of [18F]F-fluciclovine positron emission tomography/computed tomography for staging muscle invasive bladder cancer preceding radical cystectomy. Eur J Nucl Med Mol Imaging. 2025 Sep;52(11):4092-4101. doi: 10.1007/s00259-025-07287-y. Epub 2025 Apr 21.
PubMed 40257614
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of 18Fluorine-Fluciclovine Positron Emission Tomography/Computed Tomography for Staging Muscle Invasive Bladder Cancer Preceding Radical Cystectomy
- ClinicalTrials.gov ID
- NCT04018053
- Acronym / sponsor ID
- 19-208
- Conditions
- Bladder Cancer, Urothelial Carcinoma
- Keywords
- Bladder cancer, urothelial carcinoma, cystectomy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Blue Earth Diagnostics
- Study start
- 26 Feb 2020 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 25 Sep 2025 (actual)
- First posted
- 12 Jul 2019 (actual)
- Results
- Posted 9 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study is studying a positron emission tomography (PET) agent called 18F-fluciclovine to evaluate how well 18F-fluciclovine-PET scans determine the extent of muscle invasive bladder cancer (as compared to regular CT and MRI imaging) and whether 18F-fluciclovine-PET scans can provide information about the pathologic grade of the tumor.
Detailed description
This research study is a pilot study, which is the first-time investigators are examining this study imaging agent, 18F-fluciclovine, for use in imaging bladder cancer.
Staging of muscle invasive bladder cancer is currently done using computed tomography (CT) and/or magnetic resonance imaging (MRI). Both CT and MRI are useful to determine the extent of bladder cancer, but some studies show that up to 40% of patients with negative CT or MRI scans for disease outside the bladder are found to have disease outside the bladder (in lymph nodes near the bladder) at the time of surgery.
Given the limitations of the imaging exams currently used for staging bladder cancer, new techniques and imaging agents that can better identify metastatic lesions, especially within the pelvis, are desired and would be very useful.
18F-fluciclovine is a new radiotracer that was recently approved to evaluate lesions in recurrent prostate cancer (but not for bladder cancer). This radiotracer targets amino-acid receptors, which are overexpressed in multiple cancers. Studies have shown that 18F-fluciclovine PET/CT can visualize other types of cancers, such as breast cancer. A major advantage of 18F-fluciclovine is that it does not get into the bladder during the time of imaging. This may make it easier to see disease in the pelvis that is outside the bladder.
The purpose of this study to determine whether 18F-fluciclovine PET/CT can better stage muscle invasive bladder cancer compared to conventional CT or MRI. A secondary aim of this study is to determine whether 18F-fluciclovine PET/CT can reveal the pathologic grade of the bladder cancer, which is only determined from pathology specimens obtained at surgery.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 18F-fluciclovine | Experimental | Drug: 18F-fluciclovine, Device: PET/CT* 18F-fluciclovine will be administered via slow push over 10 seconds through a peripheral intravenous line * Immediately after the injection of the radiopharmaceutical, dynamic PET/CT images of the pelvis will be obtained for 15 minutes * Subsequently, PET/CT images will be obtained from the pelvis to the base of skull. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Participants must have histologically or cytologically confirmed urothelial carcinoma of the bladder.
- Participants must have cT2-T4N0 disease at the time of the study, as defined by conventional CT or MRI imaging. Patients must have no definite evidence of locoregional or distant metastatic disease at the time of study eligibility, as defined by conventional imaging.
- Radical cystectomy must be planned for the patient after the planned 18F-fluciclovine-PET/CT.
- Patients may or may not have had prior neoadjuvant therapy prior to this study.
- Age ≥18 years. Since no dosing or adverse event data are currently available on the use of 18F-fluciclovine in participants <18 years of age, and the majority of bladder cancer occur in the adult population [42], children are excluded from this study but will be eligible for future pediatric trials.
Key exclusion criteria (7 listed)
- Participants with other known malignancies that has required treatment in the past 3 years.
- Pregnant women are excluded from this study because 18F-fluciclovine is a radiopharmaceutical with the potential for teratogenic effects. Because of the radiation exposure to a nursing infant from 18F-fluciclovine, women who are breastfeeding are also excluded from this study.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to 18F-fluciclovine.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Contraindications for PET/CT including:
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 |
|---|---|---|
| 18F-fluciclovineAlso: Axumin18F-fluciclovine is a new radiotracer. This radiotracer targets amino-acid transporters, which are overexpressed in multiple cancers. | Drug | 18F-fluciclovine |
| PET/CTPositron emission tomography/computed tomography (PET/CT) uses small amounts of radioactive materials called radiotracers, a special camera and a computer to help evaluate organ and tissue functions. | Device | 18F-fluciclovine |
Primary outcome
Agreement Rate of Metastatic Disease Status Between 18F-fluciclovine-PET/CT and Histopathology From Radical Cystectomy
Time frame: Single session from 18F-fluciclovine PET/CT scan and single session results from pathology at radical cystectomy, up to 24 hours.
Lymph nodes will be classified as positive or negative for metastatic disease on 18F-fluciclovine PET/CT and compared to pathologic stage as determined from surgery.
2 secondary outcomes
Amount of 18F-fluciclovine Accumulation in the Primary Bladder Tumor on PET
Time frame: Time of 18F-fluciclovine PET/CT scan visit
Number of Participants With Suspected Distant Metastatic Disease by 18F-fluciclovine-PET/CT
Time frame: single session at time of 18F-fluciclovine PET/CT scan
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 40257614Ng TSC, Liu M, Robertson M, Konik A, Cheng SC, Bakht MK, Harrington K, Wolanski A, Gilbert L, Preston M, Mossanen M, Beltran H, Hirsch MS, Sonpavde G, Jacene HA. A pilot study of [18F]F-fluciclovine positron emission tomography/computed tomography for staging muscle invasive bladder cancer preceding radical cystectomy. Eur J Nucl Med Mol Imaging. 2025 Sep;52(11):4092-4101. doi: 10.1007/s00259-025-07287-y. Epub 2025 Apr 21.
- Link to pubmed citationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research
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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.
Heather Jacene, MD principal investigator
Dana-Farber Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing 18F-fluciclovine and PET/CT in people with Bladder Cancer and Urothelial Carcinoma, run by Brigham and Women's Hospital 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 9 inclusion and 7 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: finished, as of the sponsor's last update on 24 Jun 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Agreement Rate of Metastatic Disease Status Between 18F-fluciclovine-PET/CT and Histopathology From Radical Cystectomy (time frame: Single session from 18F-fluciclovine PET/CT scan and single session results from pathology at radical cystectomy, up to 24 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04018053, which also lists 1 linked publication.
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 24 Jun 2026.