CancerPhase 2NCT04271436
Immune Checkpoint Blockade Therapy Using 18F-FLT PET/CT
A Phase 2 study testing FDG PET/CT, FLT PET/CT and PET/MR in people with Cancer, run by Washington University School of Medicine.
Trial summary
In the current study, advanced positron emission tomography/computed tomography (PET/CT) and positron emission tomography/magnetic resonance (PET/MR) imaging methods will be used to validate the hypothesis that participants receiving immune checkpoint blockade (ICB) therapy, who ultimately achieve clinical benefit… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- FDG PET/CT, FLT PET/CT and PET/MR
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 22 Apr 2021to 31 Jan 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 must have histologically or cytologically confirmed diagnosis of cancer.
- Patients who are planned to receive checkpoint blockade therapy, per referring oncologist.
- Life expectancy ≥ 6 months and < 5 years.
- Disease that is measurable per RECIST 1.1.
- Age ≥18 years.
- Ability and willingness to provide informed consent
- Women of child-bearing potential must have a negative urinary or serum pregnancy test within 7 days of each imaging time point.
Who cannot join
- Patient receiving other investigational radiotracers within 14 days prior to FLT and FDG imaging time points.
- Patients receiving ICB in combination with chemotherapy.
- Immunosuppressive therapy including systemic corticosteroids except for maintenance dosing for adrenal insufficiency. Patients requiring immunosuppressive therapy during the study will no longer be eligible.
- Known additional malignancy that is progressing or requires active treatment with the exceptions of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, autoimmune diseases, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Patients with a pacemaker, stainless steel aneurysm clip or any other magnetic resonance (MR) contraindicated implant or foreign body would warrant exclusion from this study. Pacemakers may be reprogrammed or turned off by the strong MRI magnetic field. Radio-frequency (RF) fields in MR can also cause severe heating of pacemaker lead tips. Steel aneurysm clips are prone to torque in the strong MR field which can displace the clips and may damage the vessel, resulting in hemorrhage, and/or death.
- Pregnant women are excluded from this study
About this study
Official title: Early Assessment of Response to Immune Checkpoint Blockade Therapy Using 18F-FLT PET/CT
In the current study, advanced positron emission tomography/computed tomography (PET/CT) and positron emission tomography/magnetic resonance (PET/MR) imaging methods will be used to validate the hypothesis that participants receiving immune checkpoint blockade (ICB) therapy, who ultimately achieve clinical benefit, will show an increase, or "FLARE", in tumor FLT and/or FDG uptake from baseline, as seen after cycle#1 of treatment, and that after 2 cycles of treatment responders will have a decline in FLT and FDG uptake, in comparison to the participants classified as "non-responders".
- Conditions
- Cancer
- Being tested
- FDG PET/CT, FLT PET/CT, PET/MR, [F-18] flurothymidine
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FDG PET/CTDevice
A single dose of 10 mCi FDG will be given by bolus injection approximately 60 minutes prior to the first planned imaging procedure.
FLT PET/CTDevice
. A single dose of 10 mCi FLT will be given by bolus injection approximately 80 minutes prior to the first planned imaging procedure.
PET/MRDevice
MR imaging will be performed on a Siemens Biograph mMR or an MRI scanner, if the PET/MR is unavailable.
[F-18] flurothymidineDrug
-Radiopharmaceutical
| Study group | Role | What they receive |
|---|---|---|
| PET/CT + PET/MR | Experimental | -Eligible patients will have imaging assessments (as part of the study) performed at three time-points: pre-treatment, following cycle 1 of treatment, and following cycle 2 of treatment. Baseline FDG PET/CT will be a standard-of-care procedure. If possible, PET/CT imaging will be performed, followed immediately by PET/MR imaging during each imaging session. At minimum, PET/MR should be obtained at least once during each time-point (i.e. either during the FDG or FLT procedure). FDG imaging and FLT imaging should be performed at least 24 hours apart and no more than 7 days apart. Receives: Device: FDG PET/CT; Device: FLT PET/CT; Device: PET/MR; Drug: [F-18] flurothymidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in FLT uptake
- Participants will be designated as responders or non-responders based on follow-up RECIST 1.1 measurements
- Changes in FLT uptake will be compared between the two groups
Measured: Between pre-treatment PET/CT imaging and end of cycle 1 PET/CT imaging (estimated to be 1 month)
Change in FLT uptake
- Participants will be designated as responders or non-responders based on follow-up RECIST 1.1 measurements
- Changes in FLT uptake will be compared between the two groups
Measured: Between pre-treatment PET/CT imaging and end of cycle 2 PET/CT imaging (estimated to be 2 months)
Secondary outcomes (3)
Change in FDG uptake
- Participants will be designated as responders or non-responders based on follow-up RECIST 1.1 measurements
- Changes in FDG uptake will be compared between the two groups
Measured: Between pre-treatment PET/CT imaging and end of cycle 1 PET/CT imaging (estimated to be 1 month)
Change in FDG uptake
- Participants will be designated as responders or non-responders based on follow-up RECIST 1.1 measurements
- Changes in FDG uptake will be compared between the two groups
Measured: Between pre-treatment PET/CT imaging and end of cycle 2 PET/CT imaging (estimated to be 2 months)
Change in apparent diffusion coefficient (ADC) on diffusion-weighted MRI (DW-MRI)
Measured: From baseline to the end of second cycle of treatment (estimated to be 2 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start22 Apr 2021
- Primary completion31 Jan 2025 (estimated)
- Study completion31 Jan 2025 (estimated)
Why it stopped: Low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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 2
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard L Wahl, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04271436
- Sponsor's protocol ID
- 201909060
- Status last verified
- Jan 2025
- First submitted
- 12 Feb 2020
- Last updated
- 7 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data may be shared with other researchers. The researchers may be doing research at Washington University, at other research centers and institutions, or industry sponsors of research. Data may also be shared with large data repositories. The researchers may be doing research in areas similar to this research or in other unrelated areas.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Assessment of Response to Immune Checkpoint Blockade Therapy Using 18F-FLT PET/CT
- ClinicalTrials.gov ID
- NCT04271436
- Acronym / sponsor ID
- 201909060
- Conditions
- Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Low accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 22 Apr 2021 (actual)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 17 Feb 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.
In the current study, advanced positron emission tomography/computed tomography (PET/CT) and positron emission tomography/magnetic resonance (PET/MR) imaging methods will be used to validate the hypothesis that participants receiving immune checkpoint blockade (ICB) therapy, who ultimately achieve clinical benefit, will show an increase, or "FLARE", in tumor FLT and/or FDG uptake from baseline, as seen after cycle#1 of treatment, and that after 2 cycles of treatment responders will have a decline in FLT and FDG uptake, in comparison to the participants classified as "non-responders".
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PET/CT + PET/MR | Experimental | Device: FDG PET/CT, Device: FLT PET/CT, Device: PET/MR, Drug: [F-18] flurothymidine-Eligible patients will have imaging assessments (as part of the study) performed at three time-points: pre-treatment, following cycle 1 of treatment, and following cycle 2 of treatment. Baseline FDG PET/CT will be a standard-of-care procedure. If possible, PET/CT imaging will be performed, followed immediately by PET/MR imaging during each imaging session. At minimum, PET/MR should be obtained at least once during each time-point (i.e. either during the FDG or FLT procedure). FDG imaging and FLT imaging should be performed at least 24 hours apart and no more than 7 days apart. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients must have histologically or cytologically confirmed diagnosis of cancer.
- Patients who are planned to receive checkpoint blockade therapy, per referring oncologist.
- Life expectancy ≥ 6 months and < 5 years.
- Disease that is measurable per RECIST 1.1.
- Age ≥18 years.
Key exclusion criteria (7 listed)
- Patient receiving other investigational radiotracers within 14 days prior to FLT and FDG imaging time points.
- Patients receiving ICB in combination with chemotherapy.
- Immunosuppressive therapy including systemic corticosteroids except for maintenance dosing for adrenal insufficiency. Patients requiring immunosuppressive therapy during the study will no longer be eligible.
- Known additional malignancy that is progressing or requires active treatment with the exceptions of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, autoimmune diseases, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
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 |
|---|---|---|
| FDG PET/CTA single dose of 10 mCi FDG will be given by bolus injection approximately 60 minutes prior to the first planned imaging procedure. | Device | PET/CT + PET/MR |
| FLT PET/CT. A single dose of 10 mCi FLT will be given by bolus injection approximately 80 minutes prior to the first planned imaging procedure. | Device | PET/CT + PET/MR |
| PET/MRMR imaging will be performed on a Siemens Biograph mMR or an MRI scanner, if the PET/MR is unavailable. | Device | PET/CT + PET/MR |
| [F-18] flurothymidine-Radiopharmaceutical | Drug | PET/CT + PET/MR |
Primary outcome
Change in FLT uptake
Time frame: Between pre-treatment PET/CT imaging and end of cycle 1 PET/CT imaging (estimated to be 1 month)
* Participants will be designated as responders or non-responders based on follow-up RECIST 1.1 measurements * Changes in FLT uptake will be compared between the two groups
Change in FLT uptake
Time frame: Between pre-treatment PET/CT imaging and end of cycle 2 PET/CT imaging (estimated to be 2 months)
* Participants will be designated as responders or non-responders based on follow-up RECIST 1.1 measurements * Changes in FLT uptake will be compared between the two groups
3 secondary outcomes
Change in FDG uptake
Time frame: Between pre-treatment PET/CT imaging and end of cycle 1 PET/CT imaging (estimated to be 1 month)
Change in FDG uptake
Time frame: Between pre-treatment PET/CT imaging and end of cycle 2 PET/CT imaging (estimated to be 2 months)
Change in apparent diffusion coefficient (ADC) on diffusion-weighted MRI (DW-MRI)
Time frame: From baseline to the end of second cycle of treatment (estimated to be 2 months)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data may be shared with other researchers. The researchers may be doing research at Washington University, at other research centers and institutions, or industry sponsors of research. Data may also be shared with large data repositories. The researchers may be doing research in areas similar to this research or in other unrelated areas.
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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.
Richard L Wahl, M.D. principal investigator
Washington University School of Medicine
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FDG PET/CT, FLT PET/CT and PET/MR in people with Cancer, run by Washington University School of Medicine.
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 7 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: withdrawn, as of the sponsor's last update on 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Change in FLT uptake (time frame: Between pre-treatment PET/CT imaging and end of cycle 1 PET/CT imaging (estimated to be 1 month)). The study lists 2 primary outcomes in all. 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 7 Jan 2025.