18F-C-SNAT4 for Lung Cancers

Phase-Based Estimates
Stanford University, Stanford, CA
+1 More
18F-C-SNAT4 - Drug
All Sexes
Eligible conditions
Lung Cancers

Study Summary

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

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Eligible Conditions

  • Lung Cancers
  • Malignancies

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether 18F-C-SNAT4 will improve 1 primary outcome and 5 secondary outcomes in patients with Lung Cancers. Measurement will happen over the course of 1 day.

1 day
18F]-C-SNAT4 Uptake
Biodistribution of [18F]-C-SNAT4
Dosimetry of [18F]-C-SNAT4
The Maximal [18F]-C-SNAT4 Uptake as PET Radiotracer
7 days
Toxicity of [18F]-C-SNAT4
[18F]-C-SNAT4 PET Imaging Signal in Responders and Non-responders

Trial Safety

Trial Design

3 Treatment Groups

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

This trial requires 20 total participants across 3 different treatment groups

This trial involves 3 different treatments. 18F-C-SNAT4 is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

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)
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).
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).

Trial Logistics


Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 7 days
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 7 days for reporting.

Closest Location

Stanford University - Stanford, CA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
This text is saying that a hemoglobin level of 9 g/dL or higher is acceptable for a PET scan, as long as the hemoglobin level is corrected to 9 g/dL or higher using a growth factor or transfusion. show original
or other benign unconjugated hyperbilirubinemia For patients with a documented history of Gilbert's disease or other benign unconjugated hyperbilirubinemia, bilirubin levels of ≤ 1.5 x the upper limit of normal (ULN) are acceptable. show original
The patient had ANC ≥ 1.5 x 109/L without myeloid growth factor support for 7 days preceding lab assessment. show original
A person's platelet count must be at least 100 x 109/L for seven days before their lab assessment in order to be eligible for a blood transfusion. show original
ALT ≤ 2.5 x ULN
AST ≤ 2.5 x ULN
There is a low level of alkaline phosphatase in the blood. show original
A negative early pregnancy test (EPT) indicates that a woman is not pregnant. show original
The person has a good performance status. show original
Ability to understand and the willingness to sign a written informed consent document

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are common treatments for lung cancers?

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Lung cancer is frequently treated using a range of treatments, including combinations of different forms of therapy. The most common forms of treatment are surgery, chemotherapy, and radiation therapy.

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What is lung cancers?

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The most frequent age to present with [lung cancer](https://www.withpower.com/clinical-trials/lung-cancer) is age 70 or older, with both women and men being diagnosed. Most patients live a decade or more after diagnosis which makes it an important disease to detect before it is diagnosed too late. The majority of patients with lung cancer are diagnosed at an advanced stage, as is often the case with all cancers. Survival is low despite advances in treatment. Lung cancer is a curable disease with the advancement of surgery, chemotherapy and radiation as well as newer targeted therapies being developed. Survival is affected by the cancer stage but is not modified by tumor grade.

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How many people get lung cancers a year in the United States?

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About 235,000 lung cancers will be diagnosed in 2022. This is a substantial increase from the number of lung cancers diagnosed in 2000 (140,000). The increase is particularly noticeable among men and current smokers, and among younger adults. Because smoking increases a person's risk of developing lung cancers during all age ranges, it is anticipated that smoking prevalence will continue to increase during this period.

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Can lung cancers be cured?

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Recent findings of this study confirm the poor response to treatment and poor prognosis presented with lung cancer patients in the PSA era. The data also suggest that most patients with lung cancer do not survive beyond an average of six months.

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What are the signs of lung cancers?

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Symptoms include cough with shortness of breath, especially dyspnoea. Some symptoms are more frequently associated with squamous cell carcinomas, while symptoms of adenocarcinoma are more likely to manifest in the presence of chest pain. Symptoms are present in 5% of people aged sixty and over. Patients with recurrent symptoms of lung cancers are more likely to show symptoms from recurrence. Lymphadenopathy is a significant indicator of adenocarcinoma. Other findings associated with lung cancers include chest deformities and palpable mass.

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What causes lung cancers?

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Tobacco is the major causative factor of [lung cancer](https://www.withpower.com/clinical-trials/lung-cancer) in our population. The role of secondhand smoke and secondhand food are of more recent acceptance. There is a high frequency of lung cancer in smokers who started working at younger ages and in people with a family history of the disease. Other factors, either nutritional or occupational, contribute to lung cancer risk. Exposure to secondhand tobacco smoking and secondhand food can adversely influence the body's immune system, which is thought to have a role in cancer development.

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What does 18f-c-snat4 usually treat?

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The initial response to (18)F-c-snat4 PET scans in lung cancer is usually very poor in patients with lung tumors. When imaging is performed for the evaluation or management of pulmonary symptoms, c-snat4 PET scanning can be used for the differential diagnosis between benign and malignant disorders.

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Has 18f-c-snat4 proven to be more effective than a placebo?

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18F-c-snat4 PET-CT, performed with PET/CT, showed an improvement in SUVmax of lung tumor lesions in 13 of 13 patients, and in 10 of 13 patients in the comparison group. The data of this study suggest that 18f-c-snat4 PET-CT is a promising tool to monitor the disease burden and for guiding palliative therapies.

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Is 18f-c-snat4 safe for people?

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The most frequent side effects included headache, fatigue, nausea and dyspepsia. The most frequently observed adverse event was a transient increase in serum creatinine level, without any association with dose or duration of treatment. The most common adverse drug reactions (ADRs) were diarrhea, asthenia, and dizziness.

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How serious can lung cancers be?

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Lung cancers are the second leading cause of cancer deaths in North America. Cancer of the lung presents in 3 ways: (1) non-small-cell lung carcinoma, which represents 85% of lung cancers; (2) small-cell lung carcinoma, which represents 2.5% of cases; and (3) lung adenocarcinoma, which accounts for ~2% of all lung cancer cases. Survival in cases of non-small-cell lung cancer is affected by the severity of disease and the overall state of the person at the time of diagnosis.

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Have there been other clinical trials involving 18f-c-snat4?

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Our clinical observation of a single person with metastatic colon cancer having a positive response to a single administration of 18f-c-snat4 suggests this agent may be effective in colon cancers as well. Further study in this patient is warranted.

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What is the average age someone gets lung cancers?

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[In the US] the age of onset of lung cancers has declined slightly since the 1970s (about 5 years earlier), reaching their peak prevalence about three decades later. This decline likely reflects changes in exposure patterns and the aging of the population, and the relative increase in numbers of smokers.

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