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Biodistribution&Pharmacokinetic of Position Emission Tomography(PET) Radiopharmaceutical 18F C SNAT4

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ClinicalTrials.gov Identifier: NCT04017819
Recruitment Status : Not yet recruiting
First Posted : July 12, 2019
Last Update Posted : August 13, 2019
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Stanford University

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.

Condition or disease Intervention/treatment Phase
Cancer Lung Cancer Drug: 18F-C-SNAT4 Procedure: Positron emission tomography (PET)/Computed tomography (CT) Scan Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Biodistribution and Pharmacokinetic Study of the Positron Emission Tomography (PET) Radiopharmaceutical [18F]-C-SNAT4
Estimated Study Start Date : December 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Healthy volunteers (Group 1)
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-SNAT4
Radiotracer- Dose 10 mCi

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

Experimental: Patients with newly diagnosed lung cancer (Group 2)
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-SNAT4
Radiotracer- Dose 10 mCi

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

Experimental: Patients with lung cancer undergoing non-surgical tx (Group 3)
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-SNAT4
Radiotracer- Dose 10 mCi

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




Primary Outcome Measures :
  1. Biodistribution of [18F]-C-SNAT4 [ Time Frame: 1 day ]
    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


Secondary Outcome Measures :
  1. Dosimetry of [18F]-C-SNAT4 [ Time Frame: 1 day ]
    Radiation dosimetry of the [18F]-C-SNAT4 radiotracer will be measured through careful monitoring of each participant's vital signs in Group 1 and group 2. Time-Activity curves will be graphed by measuring activity in various organs using multiple PET/CT scans (1 hour dynamic scan, 1 hour and 2 hours) after tracer injection. Absorbed radiation will be calculated.

  2. Toxicity of [18F]-C-SNAT4 [ Time Frame: 7 days ]
    The acute [18F]-C-SNAT4 toxicity will be assessed as related adverse events, including laboratory abnormalities, that occur within 7 days of the infusion of [18F]-C-SNAT4.

  3. 18F]-C-SNAT4 Uptake [ Time Frame: 1 day ]
    The tumor uptake of [18F]-C-SNAT4 PET will be compared with the corresponding contralateral non-cancer tissue in patients with lung cancer before the therapy in Group 2 and 3. SUVmax measurements will be taken from the pre-treatment scan.

  4. The Maximal [18F]-C-SNAT4 Uptake as PET Radiotracer [ Time Frame: 1 day ]
    The time of maximal [18F]-C-SNAT4 radiotracer uptake post-injection will be assessed in Group 2 and 3. Time-Activity Curves (TAC) will be graphed by measuring activity in tumor after tracer injection. The maximal of [18F]-C-SNAT4 radiotracer uptake post-injection in lung cancer patients will be determined from these time activity curves.

  5. [18F]-C-SNAT4 PET Imaging Signal in Responders and Non-responders [ Time Frame: 7 days ]
    The [18F]-C-SNAT4 PET scan signal from pre-therapy to one week after initiation of therapy in Group 3 will be compared both in treatment responders vs. non-responders. SUVmax will be measured in both the pre-treatment and one-week post-initiation of treatment scans.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04017819


Contacts
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Contact: Risa Jiron 650-736-1598 rjiron@stanford.edu

Locations
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United States, California
Stanford University Not yet recruiting
Stanford, California, United States, 94304
Contact: Risa Jiron       rjiron@stanford.edu   
Sponsors and Collaborators
Stanford University
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Sanjiv Gambhir, MD Stanford University

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Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT04017819     History of Changes
Other Study ID Numbers: IRB-49038
LUN0108 ( Other Identifier: OnCore )
IRB-49038 ( Other Identifier: Stanford IRB )
First Posted: July 12, 2019    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action