CancerPhase 1NCT04017819
Biodistribution & Pharmacokinetic of Position Emission Tomography (PET) Radiopharmaceutical 18F C SNAT4
A Phase 1 study testing 18F-C-SNAT4 and Positron emission tomography (PET)/Computed tomography (CT) Scan in people with Cancer and Lung Cancer, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer, Lung Cancer
- What is being tested?
- 18F-C-SNAT4 and Positron emission tomography (PET)/Computed tomography (CT) Scan
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Mar 2024to Dec 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Biodistribution and Pharmacokinetic Study of the Positron Emission Tomography (PET) Radiopharmaceutical [18F]-C-SNAT4
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.
- Conditions
- Cancer, Lung Cancer
- Being tested
- 18F-C-SNAT4, Positron emission tomography (PET)/Computed tomography (CT) Scan
- Medical subject headings
- Neoplasms, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-C-SNAT4Drug
Radiotracer- Dose 10 mCi
Positron emission tomography (PET)/Computed tomography (CT) ScanDevice
Positron emission tomography (PET)/Computed tomography (CT) Scan
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: 18F-C-SNAT4; Device: 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). Receives: Drug: 18F-C-SNAT4; Device: 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) Receives: Drug: 18F-C-SNAT4; Device: Positron emission tomography (PET)/Computed tomography (CT) Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 day
Secondary outcomes (5)
Dosimetry of [18F]-C-SNAT4
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.
Measured: 1 day
Toxicity of [18F]-C-SNAT4
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.
Measured: 7 days
18F]-C-SNAT4 Uptake
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.
Measured: 1 day
The Maximal [18F]-C-SNAT4 Uptake as PET Radiotracer
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.
Measured: 1 day
[18F]-C-SNAT4 PET Imaging Signal in Responders and Non-responders
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.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2019
- Study start7 Mar 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Why it stopped: funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrei H Iagaru, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04017819
- Sponsor's protocol ID
- IRB-49038
- Other IDs
- LUN0108, IRB-49038, NCI-2019-07287
- Status last verified
- Aug 2026
- First submitted
- 2 Jul 2019
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biodistribution and Pharmacokinetic Study of the Positron Emission Tomography (PET) Radiopharmaceutical [18F]-C-SNAT4
- ClinicalTrials.gov ID
- NCT04017819
- Acronym / sponsor ID
- IRB-49038
- Conditions
- Cancer, Lung Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: funding
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 7 Mar 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 12 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers (Group 1) | Active comparator | Drug: 18F-C-SNAT4, Device: Positron emission tomography (PET)/Computed tomography (CT) ScanGroup 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). |
| Patients with newly diagnosed lung cancer (Group 2) | Experimental | Drug: 18F-C-SNAT4, Device: Positron emission tomography (PET)/Computed tomography (CT) ScanGroup2 (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). |
| Patients with lung cancer undergoing non-surgical tx (Group 3) | Experimental | Drug: 18F-C-SNAT4, Device: Positron emission tomography (PET)/Computed tomography (CT) ScanGroup 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F-C-SNAT4Radiotracer- Dose 10 mCi | Drug | 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) ScanPositron emission tomography (PET)/Computed tomography (CT) Scan | Device | Healthy volunteers (Group 1), Patients with lung cancer undergoing non-surgical tx (Group 3), Patients with newly diagnosed lung cancer (Group 2) |
Primary outcome
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
5 secondary outcomes
Dosimetry of [18F]-C-SNAT4
Time frame: 1 day
Toxicity of [18F]-C-SNAT4
Time frame: 7 days
18F]-C-SNAT4 Uptake
Time frame: 1 day
The Maximal [18F]-C-SNAT4 Uptake as PET Radiotracer
Time frame: 1 day
[18F]-C-SNAT4 PET Imaging Signal in Responders and Non-responders
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrei H Iagaru, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 18F-C-SNAT4 and Positron emission tomography (PET)/Computed tomography (CT) Scan in people with Cancer and Lung Cancer, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biodistribution of [18F]-C-SNAT4 (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.