NCT04017819

Brief Summary

Primary Objectives

  • Determine the biodistribution of \[18F\]-C-SNAT4 in 5 healthy volunteers. Secondary Objectives
  • Determine the dosimetry of \[18F\]-C-SNAT4 PET in healthy volunteers and patients with lung cancer.
  • Determine the acute toxicity of \[18F\]-C-SNAT4 PET in healthy volunteers and patients with lung cancer.
  • Determine whether uptake in \[18F\]-C-SNAT4 PET imaging is significantly different in tumor and corresponding contralateral noncancer tissue in patients with lung cancer (tested by Wilcoxon test) before the therapy.
  • Determine/verify the safety profile of the \[18F\]-C-SNAT4 radiotracer, as an imaging agent in patients with lung cancer.
  • Determine the time of maximal \[18F\]-C-SNAT4 radiotracer uptake post injection.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
20

participants targeted

Target at P25-P50 for phase_1 cancer

Timeline
Completed

Started Mar 2024

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 2, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 12, 2019

Completed
4.7 years until next milestone

Study Start

First participant enrolled

March 7, 2024

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

November 5, 2025

Status Verified

November 1, 2025

Enrollment Period

2.2 years

First QC Date

July 2, 2019

Last Update Submit

November 3, 2025

Conditions

CancerLung Cancer

Outcome Measures

Primary Outcomes (1)

  • Biodistribution of [18F]-C-SNAT4

    Whole-body \[18F\]-C-SNAT4 PET scans will be performed at 60 min post intravenous injection of the PET tracer in Group 1 of 5 healthy volunteers

    1 day

Secondary Outcomes (5)

  • Dosimetry of [18F]-C-SNAT4

    1 day

  • Toxicity of [18F]-C-SNAT4

    7 days

  • 18F]-C-SNAT4 Uptake

    1 day

  • The Maximal [18F]-C-SNAT4 Uptake as PET Radiotracer

    1 day

  • [18F]-C-SNAT4 PET Imaging Signal in Responders and Non-responders

    7 days

Study Arms (3)

Healthy volunteers (Group 1)

ACTIVE COMPARATOR

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).

Drug: 18F-C-SNAT4Device: Positron emission tomography (PET)/Computed tomography (CT) Scan

Patients with newly diagnosed lung cancer (Group 2)

EXPERIMENTAL

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).

Drug: 18F-C-SNAT4Device: Positron emission tomography (PET)/Computed tomography (CT) Scan

Patients with lung cancer undergoing non-surgical tx (Group 3)

EXPERIMENTAL

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)

Drug: 18F-C-SNAT4Device: Positron emission tomography (PET)/Computed tomography (CT) Scan

Interventions

18F-C-SNAT4DRUG

Radiotracer- Dose 10 mCi

Healthy volunteers (Group 1)Patients with lung cancer undergoing non-surgical tx (Group 3)Patients with newly diagnosed lung cancer (Group 2)
Positron emission tomography (PET)/Computed tomography (CT) ScanDEVICE

Positron emission tomography (PET)/Computed tomography (CT) Scan

Healthy volunteers (Group 1)Patients with lung cancer undergoing non-surgical tx (Group 3)Patients with newly diagnosed lung cancer (Group 2)

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ANC ≥ 1.5 x 109/L without myeloid growth factor support for 7 days preceding lab assessment
  • 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
  • Platelet count ≥ 100 x 109/L w/o blood transfusions for 7 days preceding lab assessment
  • Bilirubin ≤ 1.5 x upper limit of normal (ULN) except for pts with documented history of Gilbert's disease
  • ALT ≤ 2.5 x ULN
  • AST ≤ 2.5 x ULN
  • Alkaline phosphatase (AP) ≤ 3 x ULN
  • If a women of childbearing potential (WCBP): negative early pregnancy test (EPT)
  • Karnofsky Performance Status (KPS) ≥ 60
  • Ability to understand and the willingness to sign a written informed consent document

You may not qualify if:

  • Has already begun non-surgical therapy for any recurrence, prior to the first \[18F\]-C-SNAT4 PET/CT scan
  • Severe/uncontrolled inter-current illness within the previous 28 days prior to PET scan.
  • Any other significant co-morbid conditions that in the opinion of the Investigator would impair study participation or cooperation.
  • History of allergic reactions to IV contrasts or reactions attributed to compounds of similar chemical or biological composition to \[18F\]-C-SNAT4 used in study.
  • Pregnant or nursing
  • Patients who exceed the safe weight limit of the PET/CT bed (204.5 kg) or who cannot fit through the PET/CT bore (diameter 70 cm).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University

Stanford, California, 94304, United States

Location

MeSH Terms

Conditions

NeoplasmsLung Neoplasms

Interventions

Positron-Emission TomographyRadionuclide Imaging

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Tomography, Emission-ComputedImage Interpretation, Computer-AssistedDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisImage EnhancementPhotographyTomographyDiagnostic Techniques, Radioisotope

Study Officials

  • Andrei H Iagaru, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2019

First Posted

July 12, 2019

Study Start

March 7, 2024

Primary Completion

May 1, 2026

Study Completion

May 1, 2026

Last Updated

November 5, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)