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Lung CarcinomaPhase 2NCT02448225

18F-FSPG PET/CT in Imaging Patients With Newly Diagnosed Lung Cancer or Indeterminate Pulmonary Nodules

A Phase 2 study testing Computed Tomography, fluorodeoxyglucose F-18 and Fluorine F 18 L-glutamate Derivative BAY94-9392 in people with Lung Carcinoma and Solitary Pulmonary Nodule, run by Vanderbilt-Ingram Cancer Center at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This clinical trial compares fluorine F 18 L-glutamate derivative BAY94-9392 (18F-FSPG) positron emission tomography (PET)/computed tomography (CT) to the standard of care fluorodeoxyglucose F-18 (18F-FDG) PET/CT in imaging patients with newly diagnosed lung cancer or indeterminate pulmonary nodules. Read more about this study

Who is it for?
Ages 40 to 80 years
What is being tested?
Computed Tomography, fluorodeoxyglucose F-18 and Fluorine F 18 L-glutamate Derivative BAY94-9392
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
2 sitesUnited States
Study dates
16 Jun 2015to 10 Oct 2022
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 40 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Have an indeterminate untreated pulmonary nodule (IPN) (7-30 mm diameter) on CT, or an indeterminate lung mass (> 30 mm diameter), without prior examinations that establish that the lesion has been stable for two or more years, untreated.
  • or
  • Have a newly diagnosed, untreated primary lung cancer diameter 7 mm or more.
  • Be able to give informed consent, which will include a layman's explanation of the estimated amount of additional radiation that the patient will receive from the investigational PET/CT scan using 18F-FSPG
  • Must agree at the time of study entry to undergo clinically indicated biopsy(ies) or a 24-month period of follow-up, as needed, to resolve the etiology of their IPN(s) or lung mass(es).

Who cannot join

  • Pregnant or lactating patients will be excluded, as will females of childbearing potential who refuse to undergo a serum or urinary beta-HCG pregnancy test the day of either the 18F-FSPG or the 18F-FDG PET/CT scans, in accordance with the standard policy of the Medical Imaging Service at our facility. Women who have experienced 24 consecutive months of amenorrhea, have reached at least 60 years of age, or have had a tubal ligation or hysterectomy documented in their medical records are considered not to be of childbearing potential for the purposes of this protocol
  • Patients with a body weight of 400 pounds or more or a body habitus or disability that will not permit the imaging protocol to be performed
  • A recognized active lung infection
  • Previous systemic or radiation treatment for cancer of any type within 1 year
  • For patients who do not have a tissue diagnosis:
  • Non-oncologic severe co-morbidities suggesting a life span of less than two years if not treated, as determined by the potential subject's treating physician.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Tennessee Valley Health System Nashville

    Nashville, Tennessee, 37212

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37232

Other trials in United States

About this study

Official title: PET Imaging of Lung Cancer and Indeterminate Pulmonary Nodules With 18F-FSPG

This clinical trial compares fluorine F 18 L-glutamate derivative BAY94-9392 (18F-FSPG) positron emission tomography (PET)/computed tomography (CT) to the standard of care fluorodeoxyglucose F-18 (18F-FDG) PET/CT in imaging patients with newly diagnosed lung cancer or indeterminate pulmonary nodules. PET/CT uses a radioactive glutamate (one of the common building blocks of protein) called 18F-FSPG which may be able to recognize differences between tumor and healthy tissue. Since tumor cells are growing, they need to make protein, and other building blocks, for cell growth that are made from glutamate and other molecules. PET/CT using a radioactive glutamate may be a more effective method of diagnosing lung cancer than the standard PET/CT using a radioactive glucose (sugar), such as 18F-FDG.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To compare the imaging characteristics of 18F-FSPG PET/CT with standard-of-care, 18F-FDG PET/CT.

II. To compare the imaging characteristics of 18F-FSPG PET/CT to standard-of-care 18F-FDG PET/CT in patients with newly diagnosed lung cancer.

III. To determine whether 18F-FSPG uptake in lung cancer can be predicted based on correlation with CD44 and amino acid transport system xc- (xC-) expression in surgical pathology specimens.

OUTLINE:

Patients undergo 18F-FDG PET/CT scan per standard of care. Within 15 working days, patients also undergo 18F-FSPG PET scan over 60 minutes followed by an 18F-FSPG PET/CT scan over 30 minutes.

After completion of study, patients are followed up for 2 years if needed for diagnosis.

Being tested
Computed Tomography, fluorodeoxyglucose F-18, Fluorine F 18 L-glutamate Derivative BAY94-9392, Laboratory Biomarker Analysis, Positron Emission Tomography
Medical subject headings
Lung Neoplasms, Solitary Pulmonary Nodule, Cigarette Smoking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography

    Undergo 18F-FDG PET/CT - standard of care

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography

    Undergo 18F-FSPG PET/CT

  • fluorodeoxyglucose F-18Radiation

    Also called 18FDG, FDG, Fluorine-18 2-Fluoro-2-deoxy-D-Glucose

    Undergo 18F-FDG PET/CT - standard of care

  • Fluorine F 18 L-glutamate Derivative BAY94-9392Drug

    Also called (S)-4-(3-18F-fluoropropyl)-L-glutamic Acid, 18F-FSPG, BAY94-9392

    Undergo 18F-FSPG PET/CT

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • Positron Emission TomographyProcedure or surgery

    Also called Medical Imaging, Positron Emission Tomography, PET, PET SCAN, Positron Emission Tomography Scan

    Undergo 18F-FDG PET/CT - standard of care

  • Positron Emission Tomography (PET)Procedure or surgery

    Also called Medical Imaging, Positron Emission Tomography, Positron Emission Tomography Scan, proton magnetic resonance spectroscopic imaging

    Undergo 18F-FSPG PET/CT

Study groups in NCT02448225
Study groupRoleWhat they receive
Diagnostic (18F-FDG PET/CT, 18F-FSPG PET/CT)ExperimentalPatients undergo 18F-FDG PET/CT scan per standard of care. Within 15 working days, patients also undergo 18F-FSPG PET scan over 60 minutes followed by an 18F-FSPG PET/CT scan over 30 minutes.
Receives: Procedure: Computed Tomography; Radiation: fluorodeoxyglucose F-18; Drug: Fluorine F 18 L-glutamate Derivative BAY94-9392; Other: Laboratory Biomarker Analysis; Procedure: Positron Emission Tomography; Procedure: Positron Emission Tomography (PET)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Ability of 18F-FSPG PET/CT to Discriminate Benign From Malignant Nodules

    Sensitivity, specificity, overall accuracy and receiver operating characteristic (ROC) curves will be generated and compared for both 18F-FDG and 18F-FSPG tests.

    Sensitivity is the proportion of High(positive) among cancer patients. Specificity is the proportion of low(negative) among benign tumors. Accuracy is the proportion of correctly diagnosed among analyzed patients. Area under the curve(AUC) is the area under the ROC curve, which is the plot of sensitivity by 1-specificity.

    Measured: Up to 2 years

Secondary outcomes (3)

  1. CD44 and xC- Expression Levels in Tissue Samples(0-3)

    The level of expression of xCT and CD44 proteins in the cytoplasmic membrane of tumor cells were examined by an experienced pathologist who was blinded to any patient and imaging information. The percentage of tumor cells positive for the marker and the intensity of staining were evaluated, the latter using a scale of 0 (none), 1+ (weak), 2+ (intermediate), and 3+ (strong) with a sample being reported as positive if greater than 10% of the tumor cells in the sample were positively stained with any intensity.

    Measured: Up to 2 years

  2. Uptake of 18F-FSPG (Expressed in Maximal Standardized Uptake Value [SUV] Within the Tumor)

    Maximum standardized uptake values (SUVmax) were normalized to lean body mass and measured with a 1 cm diameter round region of interest over the area of greatest uptake in the lesion being measured.

    Measured: Up to 2 years

  3. Ability of 18F-FSPG PET/CT to Stage of Lung Cancer (Metastatic or Not)

    Sensitivity, specificity, overall accuracy and ROC curves will be generated and compared for both 18F-FDG and 18F-FSPG tests. Wilcoxon rank-sum or Kruskal-Wallis tests will be applied for the group comparisons of the biodistribution characteristics of 18F-FDG and 18F-FSPG tests.

    Sensitivity is the proportion of High(positive) among cancer patients. Specificity is the proportion of low(negative) among benign tumors. Accuracy is the proportion of correctly diagnosed among all patients. Area under the curve(AUC) is the area under the ROC curve.

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2015 (estimated)
  2. Study start16 Jun 2015
  3. Primary completion2 Aug 2021
  4. Study completion10 Oct 2022

Resources

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 2
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02448225
Sponsor's protocol ID
VICC THO 1524
Other IDs
NCI-2015-00748, P30CA068485
Status last verified
Oct 2022
First submitted
15 May 2015
Last updated
19 Oct 2022
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Computed Tomography, fluorodeoxyglucose F-18 and Fluorine F 18 L-glutamate Derivative BAY94-9392 in people with Lung Carcinoma and Solitary Pulmonary Nodule, run by Vanderbilt-Ingram Cancer Center at 2 sites 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 5 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: finished, as of the sponsor's last update on 19 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Ability of 18F-FSPG PET/CT to Discriminate Benign From Malignant Nodules (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02448225.

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 19 Oct 2022.

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