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Radiopharmaceutical

18F-C-SNAT4 for Lung Cancer

Phase 1 & 2
Waitlist Available
Led By Sanjiv Gambhir, MD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Karnofsky Performance Status (KPS) ≥ 60
Hgb ≥ 9 g/dL (90 g/L); < 9 g/dL (< 90 g/L) is acceptable if Hgb corrected to ≥ 9 g/dL (90 g/L) as by growth factor or transfusion prior to PET scan
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 days
Awards & highlights

Study Summary

This trial is testing a new imaging agent, [18F]-C-SNAT4, to see if it can help distinguish between cancer and noncancerous tissue in the lungs. The study will also look at the safety of the agent and how it is metabolized by the body.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects may include allergic reactions similar to those from IV contrasts or other compounds related to the radiotracer. The full range of side effects will be determined during the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can care for myself but may need occasional help.
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My hemoglobin level is at least 9 g/dL, or has been corrected to this level.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Biodistribution of [18F]-C-SNAT4
Secondary outcome measures
18F]-C-SNAT4 Uptake
Dosimetry of [18F]-C-SNAT4
The Maximal [18F]-C-SNAT4 Uptake as PET Radiotracer
+2 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Patients with newly diagnosed lung cancer (Group 2)Experimental Treatment2 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 Treatment2 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 Control2 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).

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,374 Previous Clinical Trials
17,332,907 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,679 Previous Clinical Trials
6,910,662 Total Patients Enrolled
Sanjiv Gambhir, MDPrincipal InvestigatorStanford University
1 Previous Clinical Trials

Media Library

18F-C-SNAT4 (Radiopharmaceutical) Clinical Trial Eligibility Overview. Trial Name: NCT04017819 — Phase 1 & 2
Cancer Research Study Groups: Patients with lung cancer undergoing non-surgical tx (Group 3), Patients with newly diagnosed lung cancer (Group 2), Healthy volunteers (Group 1)
Cancer Clinical Trial 2023: 18F-C-SNAT4 Highlights & Side Effects. Trial Name: NCT04017819 — Phase 1 & 2
18F-C-SNAT4 (Radiopharmaceutical) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04017819 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are we still able to sign up patients for this experiment?

"According to the latest information on clinicaltrials.gov, this particular trial is not seeking patients at the moment. Although, it's worth noting that there are 900 other trials with open recruitment at present. This study was originally posted on December 1st, 2022 and was last updated on November 9th, 2022."

Answered by AI
~13 spots leftby Dec 2024