NCT06457789CompletedPhase 2/3
Evaluating T Cell Changes and Activation in Cancer Patient Using Two PET Tracers (iRelate)
Source: EU CTIS (euclinicaltrials.eu) · Last updated 30 Jan 2025
Brief summary (registry, in English)
Primary objectives: To measure the spatial correlation of PET uptake of [18F]F-AraG and [89Zr]Zr-Df-Crefmirlimab in tumors and T-cell rich organs such as lymph nodes prior to resection. To measure the strength of correlation between the presence of CD8+ cells and T cell activation features in the resected tumor and lymph nodes with preoperative uptake of [89Zr]Zr-Df-Crefmirlimab and [18F]F-AraG, respectively.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 34 (actual)
- First submitted
- 28 Feb 2024
- Start date
- 29 May 2024
- Lead sponsor
- Amsterdam UMC
- Diseases
- Melanoma, Lung cancer, Gastric and esophageal cancer
- NCT number
- NCT06457789
- EU CT number
- 2023-509486-20-00
What you commit to
- Study type: Interventional · Phase 2/3
- Participants enrolled: 34
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- A patient who meets any of the following criteria will be excluded from participation in this study: 1. Patients deemed inoperable 2. Patients 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. 3. Psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. 4. Patient is pregnant or breastfeeding or expecting to conceive within the projected duration of the trial.
Who the study is looking for
- To be eligible to participate in this study, a patient must meet all of the following criteria: 1. Histologically confirmed NSCLC, melanoma, esophageal or triple negative breast cancer 2. Lesion size of ≥2cm, at time of the (re)staging FDG PET/CT 3. Planned to undergo resection according to routine treatment guidelines 4. Neoadjuvant chemotherapy + IO is allowed 5. Willing and able to provide written informed consent for the trial 6. Above 18 years of age on day of signing informed consent 7. Have measurable disease based on RECIST 1.15 8. Have a ECOG performance status of 0-1, and are considered operable based on pulmonary function test and/or exercise testing
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Amsterdam UMC Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.