Fluorine F 18 L-glutamate Derivative BAY94-9392 for Multiple Pulmonary Nodules

Phase-Based Estimates
1
Effectiveness
2
Safety
Stanford Cancer Institute Palo Alto, Palo Alto, CA
Multiple Pulmonary Nodules+4 More
Fluorine F 18 L-glutamate Derivative BAY94-9392 - Drug
Eligibility
18+
All Sexes
Eligible conditions
Multiple Pulmonary Nodules

Study Summary

This study is evaluating whether a new imaging agent may help diagnose lung cancer earlier.

See full description

Eligible Conditions

  • Multiple Pulmonary Nodules
  • Former Smoker
  • Current Smokers
  • Cigarette Smokers
  • Pulmonary Nodules

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Fluorine F 18 L-glutamate Derivative BAY94-9392 will improve 1 primary outcome and 1 secondary outcome in patients with Multiple Pulmonary Nodules. Measurement will happen over the course of Up to 5 years.

Up to 5 years
Fluorine F 18 L-glutamate derivative BAY94-9392 (18F-FSPG) specificity for malignant lung nodules
Improved performance of prediction model for lung nodules

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

2 Treatment Groups

Control
Diagnostic (18F-FSPG PET/CT, 18F-FDG PET/CT)

This trial requires 50 total participants across 2 different treatment groups

This trial involves 2 different treatments. Fluorine F 18 L-glutamate Derivative BAY94-9392 is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Diagnostic (18F-FSPG PET/CT, 18F-FDG PET/CT)Patients receive 18F-FSPG IV and, undergo a PET/CT scan over 30-60 minutes. Within 24 hours-14 days, patients receive 18F-FDG IV and undergo a second PET/CT scan over 30-60 minutes.
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Computed Tomography
2017
Completed Phase 2
~3460
Positron Emission Tomography
2019
Completed Phase 2
~2950
Fludeoxyglucose (18F)
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 5 years for reporting.

Closest Location

Stanford Cancer Institute Palo Alto - Palo Alto, CA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Pulmonary nodule between the size of 7 to 30 mm. Subjects with multiple nodules may be eligible if the dominant nodule is 7 to 30 mm
Undergoing standard of care 18F-FDG PET imaging (for indeterminate pulmonary nodule)
Current or former cigarette smoker, with >= 20 pack years
Documented informed consent

Patient Q&A Section

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

Can multiple pulmonary nodules be cured?

Add answer

The majority of the patients (94%) were managed with a total of 1060 procedures. The nodules' regression rate was 97% (nodules of 1-3 nodules responded equally good to total nodules' regression, while nodules of > 3 responded poorly.

Unverified Answer

What are common treatments for multiple pulmonary nodules?

Add answer

Although no universally accepted treatment guidelines exist for the treatment of pulmonary nodules, specific considerations should be made according to the size, shape, extent, and patient health-care setting.

Unverified Answer

What is multiple pulmonary nodules?

Add answer

In the absence of any lung disease or history of prior pulmonary disease, multiple pulmonary nodules are a common incidental finding on low-dose CT scan used to screen patients for pulmonary embolism. The majority of nodules are<4 cm. There is significant overlap in prevalence of multiple nodules among patients with and without pulmonary embolism, suggesting that a noninvasive diagnostic test for pulmonary embolism is not yet available.

Unverified Answer

How many people get multiple pulmonary nodules a year in the United States?

Add answer

The number of patients with multiple pulmonary nodules a year in the United States is not known with reasonable accuracy. More than 30 have been misclassified as benign fibrous pseudotumours on computed tomography because of mistaken interpretation of CT findings in the setting of multiple pulmonary nodules. This confusion is due to the similarity in appearance, and hence interpretation, of lung metastases, pleural plaques and pulmonary lipodystrophy on CT with pulmonary fibroblastic hamartoma on surgical specimens. The true incidence of multiple pulmonary nodules and the prevalence of multiple lung neoplasms should be established with careful selection of pulmonary nodules requiring surgical excision and histologic interpretation.

Unverified Answer

What causes multiple pulmonary nodules?

Add answer

There are many possible causes of multiple pulmonary nodules, including exposure to asbestos, drug toxicity, sarcoidosis, and tuberculosis. Diagnoses of multiple pulmonary nodules should be made cautiously, and a multidisciplinary approach is important.

Unverified Answer

What are the signs of multiple pulmonary nodules?

Add answer

Most patients with multiple pulmonary nodules have benign pathology detected on HRCT. The presence of halo signs on chest radiographs of patients with multiple pulmonary nodules is highly suggestive of the presence of infectious causes. HRCT-visible halo signs have a high positive predictive value (88%) and can serve as an objective marker of a particular disease process, such as a fungal infection.

Unverified Answer

Is fluorine f 18 l-glutamate derivative bay94-9392 typically used in combination with any other treatments?

Add answer

As F 18 L- glutamate is selectively accumulated in malignant tumours and its metabolism is influenced by different tumour characteristics, this justifies its use in PET/CT/MRI. The most frequently used combination is (S) -Bay94-9392 (CAS: [932-17-0, 5-fluoro-4-(phenylmethyl)phenyl]-2-\n(4′-fluoro)oxanorleucine (S) -octreotide, which is also the most frequently used combination when combined with (S)-methionine, and more rarely with (R) -metofoline or other peptides.

Unverified Answer

What does fluorine f 18 l-glutamate derivative bay94-9392 usually treat?

Add answer

There is a trend for the F18-labelled radioligand to reveal a higher SUVmax-peak ratio over time in patients with metastatic and/or recurrent tumor than in those with metastatic- or nonresidual-type nonenhancing metastatic pulmonary nodules. This trend coincides with clinical responses. Further validation is necessary.

Unverified Answer

Have there been other clinical trials involving fluorine f 18 l-glutamate derivative bay94-9392?

Add answer

The (18)F-L-Glu derivative of DOTA-TATE exhibited excellent efficacy and promising safety profiles in two patients with metastatic nonseminomatous testicular carcinoma, with no side effects or toxicity.

Unverified Answer

How serious can multiple pulmonary nodules be?

Add answer

With adequate follow-up and the use of adequate treatment, a small number of patients diagnosed with a multiple pulmonary nodule may remain asymptomatic. There is still an urgent need for early diagnostic tools and clinical trials to identify treatment options for patients with multiple pulmonary nodules.

Unverified Answer

What is the latest research for multiple pulmonary nodules?

Add answer

With the help of this article, we were able to find the latest research for multiple pulmonary nodules. From this, clinicians may be able to have a better-informed decision for treatment for multiple pulmonary nodules if informed by the latest research.

Unverified Answer

What is the primary cause of multiple pulmonary nodules?

Add answer

We conclude that [LAM was the cause of both cases of IPN and MNP. The primary cause of MNP could be IPN itself or another process, not LAM in the majority of cases]] (https://medscape.com/article/what-is-the-primary-cause-of-multiple-pulmonary-nodules).

Unverified Answer
See if you qualify for this trial
Get access to this novel treatment for Multiple Pulmonary Nodules by sharing your contact details with the study coordinator.