Cancer
Conditions
Brief 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, 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.
Interventions
DEVICEFDG PET/CT
A single dose of 10 mCi FDG will be given by bolus injection approximately 60 minutes prior to the first planned imaging procedure.
DEVICEFLT 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.
DEVICEPET/MR
MR imaging will be performed on a Siemens Biograph mMR or an MRI scanner, if the PET/MR is unavailable.
DRUG[F-18] flurothymidine
-Radiopharmaceutical
Sponsors
Washington University School of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in FLT uptake | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in FDG uptake | 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 FDG uptake will be compared between the two groups |
| Change in apparent diffusion coefficient (ADC) on diffusion-weighted MRI (DW-MRI) | From baseline to the end of second cycle of treatment (estimated to be 2 months) | — |
Outcome results
None listed