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NCT Number: NCT06457789

Assessment of PET Tracers to Evaluate T Cell Change and Activation in Relation to Immunotherapy Treatment Response in Non-Small Cell Lung Cancer

The iRelate is a PET imaging trial to compare two upcoming and promising T cell PET tracers. Following chemo-immuno therapy, as part of standard care, NSCLC patients will be recruited to receive two PET scans, shortly before their surgery. Both PET scans will be compared to each other, as well as compared to the pathological analysis of the resected tumor.

This study will provide detailed information on the unique as well as additive capacities of imaging biomarkers derived from the immune cell targeting PET tracers.

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Key information

Conditions

NSCLC

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Amsterdam UMC, location VUmc

Amsterdam, North Holland, 1081 HV, Netherlands

Location status: Recruiting

Location contact

Idris Bahce, MD, PhD

CONTACT

[email protected]

+31204444444

Idris Bahce, MD, PhD

PRINCIPAL_INVESTIGATOR

Maarten Slebe, Msc

CONTACT

[email protected]

+31204445242

Maarten Slebe, Msc

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically confirmed NSCLC
  • T1-4N0-2, lesion size of ≥2cm, at time of the restaging FDG PET/CT
  • Planned to undergo resection after chemo-IO according to routine treatment guidelines
  • Willing and able to provide written informed consent for the trial
  • Above 18 years of age on day of signing informed consent
  • Have measurable disease based on RECIST 1.1
  • Have a ECOG performance status of 0-1, and are considered operable based on pulmonary function test and/or exercise testing

Exclusion criteria

  • Patients deemed inoperable
  • Patients who have received a splenectomy
  • Patients who have received any vaccination within 14 days of enrollment
  • 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.
  • 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.

Treatment and study plan

[18F]F-AraG PET imaging

Drug

Patients will receive a static whole-body PET scan following a [18F]F-AraG injection.

[89Zr]Zr-Df-Crefmirlimab PET imaging

Drug

Patients will receive a static whole-body PET scan following a [89Zr]Zr-Df-Crefmirlimab injection.

Primary outcomes

  1. 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.

    Time frame: 2 months

    The spatial overlap of the regions of uptake for both PET tracers will be assessed using the Dice Similarity Coefficient (DSC) as an established method

  2. 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.

    Time frame: 6 months

    The Pearson correlation coefficient between each tracer tumor uptake and the T cell features in regions of concordance and discordance.

Secondary outcomes

  1. To measure the strength of correlation of pathological response (i.e., the residual viable tumor cells percentage) in the resected tumor with preoperative uptake of [89Zr]Zr-Df-Crefmirlimab and [18F]F-AraG.

    Time frame: 6 months

    The Pearson correlation coefficient between each tracer tumor uptake and percentage of residual viable tumor cells (VTC) in regions of concordance and discordance and the maximal VTC of the entire tumor. The Pearson correlation coefficient between each tracer uptake and the T cell presence in resected lymph nodes (if present).

Other outcomes

  1. To explore the association of PET uptake of both tracers in tumor and T-cell rich organs such as lymph nodes with: The immune profile of the TME and resected lymph nodes beyond T cells. The immune profile of peripheral blood mononuclear cells (PBMCs)

    Time frame: 6 months

    The Pearson correlation coefficient between PET uptake and immune profile of the TME for tumor and T-cell rich organs. The Pearson correlation coefficient between PET uptake and immune profile of PBMCs for tumor + T-cell rich organs.

  2. To quantify inter- and intra-tumoral heterogeneity of PET tracer uptake.

    Time frame: 2 months

    Voxel intensities for [18F]F-AraG and [89Zr]Zr-Df-Crefmirlimab PET images will be plotted against each other by means of scatter plots and joint histograms/kernel density plots to illustrate the degree of agreement in spatial distribution of both tracers with the VOIs.

  3. To assess the relationship of metabolically active areas as assessed by [18F]F-FDG PET with areas of uptake derived from [18F]F-AraG and [89Zr]Zr-Df-Crefmirlimab PET.

    Time frame: 4 months

    The spatial overlap of the regions of uptake for the FDG, [18F]F-AraG and [89Zr]Zr-Df-Crefmirlimab PET tracers will be assessed using the Dice Similarity Coefficient (DSC) method.

Study contacts

Contact information is provided by the study sponsor or research team.

Idris Bahce, MD, PhD

CONTACT

[email protected]

+31204444444

Maarten Slebe, Msc.

CONTACT

[email protected]

+31204445242

Sponsors and collaborators

Lead sponsor

Amsterdam UMC, location VUmc

Other

Collaborators

  • Foundation for the National Institutes of Health

Registry information

Acronym: iRelate

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Jun 13, 2024
Registry last updated
Apr 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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