18F-C-SNAT4 for Lung Cancer

Overseen By David Marcellus

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Stanford University

Disqualifiers: Severe illness, Allergic reactions, Pregnant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 1 day per dose

20 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new imaging agent called [18F]-C-SNAT4 in both healthy people and lung cancer patients. The goal is to see how the agent spreads in the body, measure its safety, and determine how well it highlights cancerous tissues compared to normal ones.

Research Team

Andrei Iagaru, MD

Principal Investigator

Stanford University

Eligibility Criteria

This trial is for healthy volunteers and lung cancer patients with normal blood counts, liver function, and no severe illnesses in the past month. Women must not be pregnant and all participants should understand the study well enough to consent.

Inclusion Criteria

Ability to understand and the willingness to sign a written informed consent document

Bilirubin ≤ 1.5 x upper limit of normal (ULN) except for pts with documented history of Gilbert's disease

ANC ≥ 1.5 x 109/L without myeloid growth factor support for 7 days preceding lab assessment

Exclusion Criteria

I have started treatment for cancer recurrence before my first PET/CT scan.

I haven't had a severe illness in the last 28 days.

I am allergic to certain IV contrasts or similar compounds.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive doses of [18F]-C-SNAT4 and undergo PET/CT scans to assess biodistribution and dosimetry

1 day per dose

3 visits (in-person) for Group 1 and 2, 2 visits (in-person) for Group 3

Follow-up

Participants are monitored for acute toxicity and safety profile of the radiotracer

7 days

Extension

Optional additional monitoring of PET imaging signal in responders and non-responders

1 week

Treatment Details

Interventions

• 18F-C-SNAT4

Trial Overview The trial tests a new PET/CT scan radiotracer called 18F-C-SNAT4. It aims to see how this tracer spreads in the body, its safety, toxicity levels, and if it can clearly show lung cancer compared to non-cancerous tissue.

Participant Groups

Group I: Patients with newly diagnosed lung cancer (Group 2) Experimental Treatment 2 Interventions

Group2 (n = 5) newly diagnosed lung cancer. Each participant in this part of the study will receive a single dose of \[18F\]-C-SNAT4 and then undergo three times of whole body (WB) PET/CT scans (Scan 1: 60 minutes dynamic scan; Scan 2: WB skull base-thigh at 90 minutes +/- 10 minutes post injection; Scan 3: WB skull base-thigh at 120 minutes +/- 10 minutes post-injection of \[18F\]-C-SNAT4).

Group II: Patients with lung cancer undergoing non-surgical tx (Group 3) Experimental Treatment 2 Interventions

Group 3 (n = 10) lung cancer after non-surgical therapy. Each participant in this part of the study will receive a total of 2 doses of \[18F\]-C-SNAT4 (on 2 separate occasions spaced at least 1 week apart, each of which will be followed by undergoing a \[18F\]-C-SNAT4 PET/CT scan)

Group III: Healthy volunteers (Group 1) Active Control 2 Interventions

Group 1(n = 5) healthy volunteers. Each participant in this part of the study will receive a single dose of \[18F\]-C-SNAT4 and then undergo three times of whole body (WB) PET/CT scans (Scan 1: 60 minutes dynamic scan; Scan 2: WB skull base-thigh at 90 minutes +/- 10 minutes post injection; Scan 3: WB skull base-thigh at 120 minutes +/- 10 minutes post-injection of \[18F\]-C-SNAT4).

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+