breast cancer esophageal cancer lung cancer lung carcinoma melanoma
Conditions
Interventions
all patients will undergo 3 [18F]F-AraG PET scanning procedures according to
the institutional protocols
Sponsors
Vrije Universiteit Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Histologically confirmed NSCLC, melanoma, esophageal, or breast cancer • Ongoing immunotherapy using an anti-PD-(L)1 agent • Planned to be treated with high dose (24Gy) radiotherapy per clinical indication • Be willing and able to provide written informed consent for the trial. • Have a performance status of 0-2 on the ECOG Performance Scale • Be above 18 years of age on day of signing informed consent.
Exclusion criteria
Exclusion criteria: • Subjects with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of day 0. Inhaled or topical steroids, and adrenal replacement steroid >10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease. • Psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. • Patient is pregnant or breastfeeding, or expecting to conceive within the projected duration of the trial, starting with the screening visit through 12 weeks after the last administration of [18F]F-AraG.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.To assess the relative change in uptake of [18F]F-AraG in tumor lesions on anti-PD-1 treatment a. To define tracer uptake in all tumor lesions and lymphoid organs (lymph nodes, spleen) per [18F]F-AraG PET scan b. To assess the changes in uptake between baseline and after 1 and 3 weeks on-treatment | — |
Countries
Netherlands
Outcome results
None listed