An Investigational Scan ([18F]-C-SNAT4 PET) for the Imaging of Lung Cancer or Healthy Volunteers
This trial studies [18F]-C-SNAT4 PET/CT in imaging patients with lung cancer or healthy volunteers. [18F]-C-SNAT4 is an imaging agent used for the detection of tumor response to therapy. Using a PET/CT scan to establish normal range of [18F]-C-SNAT4 uptake may help researchers learn how the drug behaves in the body and how the body eliminates it.
Inclusion Criteria
- HEALTHY VOLUNTEERS: Age ≥ 18 years
- HEALTHY VOLUNTEERS: Absolute neutrophil count (ANC) >= 1.5 x 10^9/L without myeloid growth factor support for 7 days preceding lab assessment (within 14 days prior to PET scan)
- HEALTHY VOLUNTEERS: Hemoglobin (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 (within 14 days prior to PET scan)
- HEALTHY VOLUNTEERS: Platelet count >= 100 x 10^9/L without (w/o) blood transfusions for 7 days preceding lab assessment (within 14 days prior to PET scan)
- HEALTHY VOLUNTEERS: Bilirubin =< 1.5 x upper limit of normal (ULN) except for patients (pts) with documented history of Gilbert’s disease (within 14 days prior to PET scan)
- HEALTHY VOLUNTEERS: Alanine aminotransferase (ALT) =< 2.5 x ULN (within 14 days prior to PET scan)
- HEALTHY VOLUNTEERS: Aspartate aminotransferase (AST) =< 2.5 x ULN (within 14 days prior to PET scan)
- HEALTHY VOLUNTEERS: Alkaline phosphatase (AP) =< 3 x ULN (within 14 days prior to PET scan)
- HEALTHY VOLUNTEERS: If a women of childbearing potential (WCBP): negative early pregnancy test (EPT)
- PATIENTS WITH LUNG CANCER AND NO TREATMENT: Age ≥ 18 years
- PATIENTS WITH LUNG CANCER AND NO TREATMENT: ANC ≥ 1.5 x 10^9 g/dL without myeloid growth factor support for 7 days preceding lab assessment
- PATIENTS WITH LUNG CANCER AND NO TREATMENT: Hgb ≥ 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
- PATIENTS WITH LUNG CANCER AND NO TREATMENT: Platelet count ≥ 100 x 10^9/L w/o blood transfusions for 7 days preceding lab assessment
- PATIENTS WITH LUNG CANCER AND NO TREATMENT: Bilirubin ≤ 1.5 x upper limit of normal (ULN) except for pts with documented history of Gilbert's disease
- PATIENTS WITH LUNG CANCER RECEIVING NON-SURGICAL TREATMENT: Age ≥ 18 years
- PATIENTS WITH LUNG CANCER RECEIVING NON-SURGICAL TREATMENT: ANC ≥ 1.5 x 10^9/L without myeloid growth factor support for 7 days preceding lab assessment
- PATIENTS WITH LUNG CANCER RECEIVING NON-SURGICAL TREATMENT: Hgb ≥ 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
- PATIENTS WITH LUNG CANCER RECEIVING NON-SURGICAL TREATMENT: Platelet count ≥ 100 x 10^9/L w/o blood transfusions for 7 days preceding lab assessment
- PATIENTS WITH LUNG CANCER RECEIVING NON-SURGICAL TREATMENT: Bilirubin ≤ 1.5 x upper limit of normal (ULN) except for pts with documented history of Gilbert’s disease
- PATIENTS WITH LUNG CANCER RECEIVING NON-SURGICAL TREATMENT: ALT ≤ 2.5 x ULN
- PATIENTS WITH LUNG CANCER RECEIVING NON-SURGICAL TREATMENT: AST ≤ 2.5 x ULN
- PATIENTS WITH LUNG CANCER RECEIVING NON-SURGICAL TREATMENT: If a women of childbearing potential (WCBP): negative early pregnancy test (EPT)
- PATIENTS WITH LUNG CANCER RECEIVING NON-SURGICAL TREATMENT: Karnofsky performance status (KPS) ≥ 60
- PATIENTS WITH LUNG CANCER RECEIVING NON-SURGICAL TREATMENT: Pathology report confirmatory of lung cancer
- PATIENTS WITH LUNG CANCER RECEIVING NON-SURGICAL TREATMENT: Undergoing non-surgical treatment for lung cancer
Exclusion Criteria
- HEALTHY VOLUNTEERS: Severe/uncontrolled inter-current illness within the previous 28 days prior to PET scan
- HEALTHY VOLUNTEERS: Prior or current malignancy
- HEALTHY VOLUNTEERS: 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
- PATIENTS WITH LUNG CANCER AND NO TREATMENT: ALT ≤ 2.5 x ULN
- PATIENTS WITH LUNG CANCER AND NO TREATMENT: AST ≤ 2.5 x ULN
- PATIENTS WITH LUNG CANCER AND NO TREATMENT: Alkaline phosphatase (AP) ≤ 3 x ULN
- PATIENTS WITH LUNG CANCER AND NO TREATMENT: If a woman of childbearing potential (WCBP): negative early pregnancy test (EPT)
- PATIENTS WITH LUNG CANCER AND NO TREATMENT: Karnofsky performance status (KPS) ≥ 60
- PATIENTS WITH LUNG CANCER AND NO TREATMENT: Pathology report confirmatory of lung cancer
- PATIENTS WITH LUNG CANCER AND WITH NO TREATMENT: Severe/uncontrolled inter-current illness within the previous 28 days prior to PET scan
- PATIENTS WITH LUNG CANCER AND NO TREATMENT: 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.
- PATIENTS WITH LUNG CANCER RECEIVING NON-SURGICAL TREATMENT: Alkaline phosphatase (AP) ≤ 3 x ULN
- PATIENTS WITH LUNG CANCER RECEIVING NON-SURGICAL TREATMENT: Severe/uncontrolled inter current illness within the previous 28 days prior to PET scan
- PATIENTS WITH LUNG CANCER RECEIVING NON-SURGICAL TREATMENT: 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
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04017819.
Locations matching your search criteria
United States
California
Palo Alto
PRIMARY OBJECTIVE:
I. Determine the biodistribution of fluorine F 18 C-SNAT4 ([18F]-C-SNAT4) in 5 healthy volunteers and 15 patients with lung cancer.
SECONDARY OBJECTIVES:
I. Determine the dosimetry of [18F]-C-SNAT4 positron emission tomography (PET) in 5 healthy volunteers and 15 patients with lung cancer.
II. Determine the acute toxicity of [18F]-C-SNAT4 PET in 5 healthy volunteers and 15 patients with lung cancer.
III. Determine whether uptake in [18F]-C-SNAT4 PET imaging is significantly different in tumor and corresponding contralateral non-cancer tissue in patients with lung cancer (tested by Wilcoxon test) before the therapy.
IV. Determine the time of maximal [18F]-C-SNAT4 radiotracer uptake post-injection.
V. Determine changes in [18F]-C-SNAT4 uptake post-therapy.
OUTLINE: Participants are assigned to 1 of 2 groups.
GROUP I: Patients with lung cancer with no treatment and healthy volunteers receive [18F]-C-SNAT4 intravenously (IV) and then undergo a whole body PET/computed tomography (CT) scan over 60 minutes, a second PET/CT scan at 60 minutes post-injection of [18F]-C-SNAT4, and a third PET/CT scan at 120 minutes post-injection of [18F]-C-SNAT4. Patients and healthy volunteers also undergo blood sample collection on study.
GROUP II: Patients with lung cancer receiving non-surgical treatment receive [18F]-C-SNAT4 and undergo whole body PET/CT scans as in Group I, and then again at 1 week post initiation of therapy. Patients undergo blood sample collection on study.
After completion of study, all participants are followed up at 24 hours and 7 days, and then at 4 weeks for healthy volunteers or up to 12 months for cancer patients.
Trial PhaseNo phase specified
Trial Typediagnostic
Lead OrganizationStanford Cancer Institute Palo Alto
Principal InvestigatorAndrei Iagaru
- Primary IDLUN0108
- Secondary IDsNCI-2019-07287
- ClinicalTrials.gov IDNCT04017819