- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04524195
PET Imaging With [18F]F-AraG in Advanced Non-small Cell Lung Cancer (NSCLC)
A Study of PET Imaging of T-cell Activation With [18F]F-AraG in Advanced Non-small Cell Lung Cancer (NSCLC) Patients Undergoing PD-1/PD-L1-directed Therapy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The purpose of this study is to find out how the radiotracer called [18F]F-AraG can help investigate changes in cancer's anti-tumor immune response (or activation of T-cell) levels during positron emission tomography (PET) scans. [18F]F-AraG has the potential to serve as a noninvasive imaging biomarker in the monitoring of T-cell mediated anti-tumor immune response following administration of an immunotherapeutic agent.
Participants in this study will have tests, exams and procedures that are for study purposes. Participants will be in this study up to one month which will include about three clinic visits.
A baseline [18F]F-AraG PET-CT will be obtained 0-7 days before a NSCLC patient receives PD-1/PD-L1 immunotherapy. A second [18F]F-AraG PET-CT will be performed 10-14 days after PD-1/PD-L1 immunotherapy is administered.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Mary K Brosnan, BA
- Phone Number: 410-955-8264
- Email: mbrosna1@jhmi.edu
Study Contact Backup
- Name: Rehab Abdallah, MB BCh
- Phone Number: 410-955-6615
- Email: rabdall1@jhmi.edu
Study Locations
-
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Maryland
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Baltimore, Maryland, United States, 21287
- Johns Hopkins University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 18 years or older and willing and able to provide informed consent.
- Subjects with stage I, II, or III A NSCLC and plan to receive neoadjuvant PD-1/PD-L1 immunotherapy with an intention for curative surgery. Subjects will be receiving neoadjuvant immunotherapy through enrollment in therapeutic clinical trials
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 at the time of enrollment.
- For females of childbearing potential, negative serum pregnancy test within a 10 day period will be obtained prior to PET study.
Exclusion Criteria:
- Severe impaired renal function with estimated glomerular filtration rate <30 mL/min/1.73 m2 and/or on dialysis.
- Pregnant female patients; breastfeeding female patients.
- Any medical condition that in the opinion of the study investigators would constitute a safety risk to the subject.
- Any investigational radiation exposure in the past calendar year that in combination with the radiation exposure from this study would exceed 5 rem.
- Administered a radioisotope ≤5 physical half-lives prior to the day of PET/CT.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: [18F]F-AraG
A one-time nominal injection dose of 5 millicurie (mCi) +/- will be administered at each PET/CT imaging time point.
|
Single dose of 5 mCi+/- [18F]F-AraG IV injection followed by the PET/CT scan.
A baseline [18F]F-AraG PET/CT will be performed at about 0-7 days before patient receives the first dose of PD-1/PD-L1 immunotherapy.
A second [18F]F-AraG PET-CT will be performed at less than 14 days after the first dose of PD-1/PD-L1 immunotherapy is administered and before the second dose of PD-1/PD-L1 immunotherapy is given.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent Change in uptake of [18F]F-AraG before and after one dose of anti-PD-L1
Time Frame: Baseline and 10-14 days after first dose of neoadjuvant therapy
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Percent Change in standard uptake value (SUV) of [18F]F-AraG PET-CT imaging of primary tumor and of lymph nodes at baseline to after the first dose of neoadjuvant therapy.
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Baseline and 10-14 days after first dose of neoadjuvant therapy
|
Percent pathologic response at the time of surgery
Time Frame: At the time of surgery
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100% minus the percentage of viable tumor remaining in the tumor bed.
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At the time of surgery
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Correlation between [18F]F-AraG uptake and percent pathologic response as assessed by the Spearman correlation coefficient
Time Frame: 5 years
|
Spearman correlation coefficient will be calculated in assessing the correlation between [18F]F-AraG uptake and pathologic response.
|
5 years
|
Collaborators and Investigators
Investigators
- Principal Investigator: Martin Pomper, M.D., Ph.D., Johns Hopkins University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- J19119
- IRB00208724 (Other Identifier: JHM IRB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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