Authorised Phase II and Phase III (Integrated) Breast cancer

Evaluating T Cell Changes and Activation in Cancer Patient Using Two PET Tracers (iRelate)

EU CTIS ID: 2023-509486-20-00

What this study is testing

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.

  • Phase II and Phase III (Integrated)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • 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

You likely can't join if

  • 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.

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.