18F-C-SNAT4 for Lung Cancer

Overseen By David Marcellus

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Stanford University

Disqualifiers: Severe illness, Allergic reactions, Pregnant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 1 day per dose

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new imaging agent called 18F-C-SNAT4 to assess its movement through the body and its safety. The study includes both healthy volunteers and individuals with lung cancer to understand how the imaging agent behaves in cancerous versus healthy tissues. Participants needed include those newly diagnosed with lung cancer, those receiving non-surgical treatment, and healthy individuals. Ideal candidates are those newly diagnosed with lung cancer or experiencing frequent symptoms who have not yet started non-surgical treatment. As a Phase 1 and Phase 2 trial, this research aims to understand the imaging agent's function in people and measure its effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking medical advancements.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that 18F-C-SNAT4 is likely to be safe for humans?

Research is examining the safety of a new imaging agent called 18F-C-SNAT4 for lung cancer patients. Early studies are assessing how well this agent is tolerated by both healthy individuals and those with lung cancer. Although detailed safety data is not yet available, the trial is in its early stages. This typically suggests the treatment is expected to be safe, but the full safety profile is still under investigation. The studies aim to identify any short-term side effects. Participants receive specific doses, and researchers closely monitor their safety using PET scans, which are imaging tests that show how the agent moves through the body. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Researchers are excited about 18F-C-SNAT4 for lung cancer because it offers a new way to see how the disease behaves in the body. Unlike traditional treatments that focus on killing cancer cells, 18F-C-SNAT4 works by acting as a tracer in PET/CT scans to provide detailed images of how the cancer is spread and how it responds to treatment. This can help doctors tailor treatments more precisely and potentially improve outcomes for patients. Additionally, by using this tracer, doctors might catch changes in the cancer sooner, allowing for faster adjustments to the treatment plan.

What evidence suggests that the 18F-C-SNAT4 radiotracer is effective for lung cancer imaging?

Research has shown that [18F]-C-SNAT4 is a promising PET imaging tool for lung cancer. This trial will evaluate [18F]-C-SNAT4 in various participant groups, including those with newly diagnosed lung cancer and those undergoing non-surgical therapy. This substance targets caspase-3, a protein involved in cell death, which often increases in cancer cells responding to treatment. Studies have demonstrated that [18F]-C-SNAT4 can clearly distinguish between cancerous and healthy tissues, making it potentially useful for assessing tumor response to therapies. Early results suggest that this imaging agent helps predict how well a tumor responds to treatments like chemotherapy and radiotherapy. While more data from human studies is still needed, initial findings are encouraging for its use in monitoring lung cancer. ^{2 6 7 8 9}

Who Is on the Research Team?

Andrei Iagaru, MD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Ability to understand and the willingness to sign a written informed consent document

Bilirubin ≤ 1.5 x upper limit of normal (ULN) except for pts with documented history of Gilbert's disease

ANC ≥ 1.5 x 109/L without myeloid growth factor support for 7 days preceding lab assessment

Exclusion Criteria

I have started treatment for cancer recurrence before my first PET/CT scan.

I haven't had a severe illness in the last 28 days.

I am allergic to certain IV contrasts or similar compounds.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive doses of [18F]-C-SNAT4 and undergo PET/CT scans to assess biodistribution and dosimetry

1 day per dose

3 visits (in-person) for Group 1 and 2, 2 visits (in-person) for Group 3

Follow-up

Participants are monitored for acute toxicity and safety profile of the radiotracer

7 days

Extension

Optional additional monitoring of PET imaging signal in responders and non-responders

1 week

What Are the Treatments Tested in This Trial?

Interventions

• 18F-C-SNAT4

Trial Overview 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.

How Is the Trial Designed?

Group I: Patients with newly diagnosed lung cancer (Group 2) Experimental Treatment 2 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 Treatment 2 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 Control 2 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).

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12133672/

C-SNAT4 PET imaging of apoptosis after radiotherapy using a ... In vivo results showed that [18F]-C-SNAT was best in predicting treatment response [36]. A 2nd generation probe, [18F]-C-SNAT4 improves ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33712870/

C-SNAT4: an improved caspase-3-sensitive nanoaggregation ... This study reports an improved 18 F-labeled caspase-sensitive nanoaggregation tracer ([ 18 F]-C-SNAT4) for PET imaging of tumor response to chemo- and ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04017819

NCT04017819 | Biodistribution&Pharmacokinetic of ... Determine whether uptake in [18F]-C-SNAT4 PET imaging is significantly different in tumor and corresponding contralateral noncancer tissue in patients with lung ...

4. researchgate.net researchgate.net/publication/350041907_18F-C-SNAT4_an_improved_caspase-3-sensitive_nanoaggregation_PET_tracer_for_imaging_of_tumor_responses_to_chemo-_and_immunotherapies

[18F]-C-SNAT4: an improved caspase-3-sensitive ... Results: In the tumor panel, 18F-AraG revealed strikingly different uptake patterns resembling cancer-immune phenotypes observed in the clinic.

5. researchgate.net researchgate.net/publication/392370596_Augmentation_of_F-C-SNAT4_PET_imaging_of_apoptosis_after_radiotherapy_using_a_cold_mixing_strategy

(PDF) Augmentation of [F]-C-SNAT4 PET imaging of ... Results [18 F]-C-SNAT4 and hot/cold mixture [18 F]/[19 F]-C-SNAT4 were used to detect human NSCLC (NCI-H460) apoptosis induced by radiation. Both hot [18 F]-C- ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04017819

NCT04017819 | Biodistribution&Pharmacokinetic of ... 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- ...

7. med.stanford.edu med.stanford.edu/mosslab/research?start=4080

Research | Moss Lab - Stanford Medicine * 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 ...

8. stanfordhealthcare.org stanfordhealthcare.org/trials/b/NCT04017819.html

Biodistribution&Pharmacokinetic of Position Emission ... * 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 \[ ...

9. researchgate.net researchgate.net/figure/F-C-SNAT4-PET-imaging-of-caspase-3-activity-following-immunotherapy-in-CT26-tumor_fig6_350041907

[¹⁸F]-C-SNAT4 PET imaging of caspase-3 activity following ... Measurements were recorded over 21 days after tumor implantation. Data are means ± s.d., ****P < 0.0001 (general linear model repeated measures). NS = not ...