PET Imaging With [18F]F-AraG in Advanced Non-small Cell Lung Cancer (NSCLC)

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Johns Hopkins Medicine

Status and phase

Terminated
Phase 1

Conditions

Non-small Cell Lung Cancer (NSCLC)

Treatments

Drug: [18F]F-AraG Injection

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT04524195
J19119
IRB00208724 (Other Identifier)

Details and patient eligibility

About

This is a prospective, single center, single-arm clinical trial in 20 patients with non-small cell lung cancer (NSCLC) undergoing PD-1/PD-L1-directed therapy. This research is being done to find out if the radioactive compound called \[18F\]F-AraG is a helpful imaging agent for detecting changes in cancer's anti-tumor immune response (or activation of T-cell) levels for non-small cell lung cancer (NSCLC) patients who will receive a cancer immunotherapy regimen (immunotherapy works by encouraging the body's own immune system to attack the cancer cells).

Full 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.

Enrollment

4 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

4 participants in 1 patient group

[18F]F-AraG
Experimental group
Description:
A one-time nominal injection dose of 5 millicurie (mCi) +/- will be administered at each PET/CT imaging time point.
Treatment:
Drug: [18F]F-AraG Injection

Trial contacts and locations

1

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Central trial contact

Rehab AbdAllah, MB BCH; Mary K Brosnan, BA

Data sourced from clinicaltrials.gov

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