NSCLCiRelateNCT06457789
Assessment of PET Tracers to Evaluate T Cell Change and Activation in Relation to Immunotherapy Treatment Response in Non-Small Cell Lung Cancer
A study testing [18F]F-AraG PET imaging and [89Zr]Zr-Df-Crefmirlimab PET imaging in people with NSCLC, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC
- What is being tested?
- [18F]F-AraG PET imaging and [89Zr]Zr-Df-Crefmirlimab PET imaging
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Dec 2024to Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Amsterdam UMC, location VUmc
Amsterdam, North Holland, 1081 HV
Maarten Slebe, Msc, +31204445242, m.slebe@amsterdamumc.nl
Idris Bahce, MD, PhD, +31204444444, i.bahce@amsterdamumc.nl
About this study
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.
- Conditions
- NSCLC
- Being tested
- [18F]F-AraG PET imaging, [89Zr]Zr-Df-Crefmirlimab PET imaging
- Keywords
- NSCLC, immunoPET, 18F-AraG, AraG, 89Zr-crefmirlimab, Crefmirlimab, tracers, PET tracers, [18F]F-AraG, [89Zr]Zr-Df-Crefmirlimab, IAB22M2C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]F-AraG PET imagingDrug
Patients will receive a static whole-body PET scan following a [18F]F-AraG injection.
[89Zr]Zr-Df-Crefmirlimab PET imagingDrug
Patients will receive a static whole-body PET scan following a [89Zr]Zr-Df-Crefmirlimab injection.
| Study group | Role | What they receive |
|---|---|---|
| Dual T cell PET imaging | Experimental | Patients will receive PET imaging with two different T-cell targeting tracers. Receives: Drug: [18F]F-AraG PET imaging; Drug: [89Zr]Zr-Df-Crefmirlimab PET imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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
Measured: 2 months
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.
The Pearson correlation coefficient between each tracer tumor uptake and the T cell features in regions of concordance and discordance.
Measured: 6 months
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.
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).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start1 Dec 2024
- Primary completionAug 2027 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies of the same condition, open and under way.
- More trials run by Amsterdam UMC, location VUmcThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation for the National Institutes of Health
- Responsible party
- Principal investigator, Idris Bahce, Amsterdam UMC, location VUmc
- Investigators
- Idris Bahce, MD, PhD, Principal investigator, Amsterdam UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06457789
- Sponsor's protocol ID
- 2023-509486-20-00
- Other IDs
- 2023-509486-20-00, 2023
- Acronym
- iRelate
- Status last verified
- Aug 2026
- First submitted
- 3 Jun 2024
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of PET Tracers to Evaluate T Cell Change and Activation in Relation to Immunotherapy Treatment Response in Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT06457789
- Acronym / sponsor ID
- iRelate / 2023-509486-20-00
- Conditions
- NSCLC
- Keywords
- NSCLC, immunoPET, 18F-AraG, AraG, 89Zr-crefmirlimab, Crefmirlimab, tracers, PET tracers
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Collaborators
- Foundation for the National Institutes of Health
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 13 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dual T cell PET imaging | Experimental | Drug: [18F]F-AraG PET imaging, Drug: [89Zr]Zr-Df-Crefmirlimab PET imagingPatients will receive PET imaging with two different T-cell targeting tracers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [18F]F-AraG PET imagingPatients will receive a static whole-body PET scan following a [18F]F-AraG injection. | Drug | Dual T cell PET imaging |
| [89Zr]Zr-Df-Crefmirlimab PET imagingPatients will receive a static whole-body PET scan following a [89Zr]Zr-Df-Crefmirlimab injection. | Drug | Dual T cell PET imaging |
Primary outcome
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
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.
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Idris Bahce, MD, PhD principal investigator
Amsterdam UMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing [18F]F-AraG PET imaging and [89Zr]Zr-Df-Crefmirlimab PET imaging in people with NSCLC, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maarten Slebe, Msc. (+31204445242, m.slebe@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.