Phase 2
N=46
18F-FSPG PET/CT in Imaging Patients With Newly Diagnosed Lung Cancer or Indeterminate Pulmonary Nodules
Lung Carcinoma · Solitary Pulmonary Nodule · Cigarette Smoking Behavior
Bottom Line
View on ClinicalTrials.gov: NCT02448225 ↗Enrolled (actual)
46
Serious AEs
2.2%
Results posted
May 2022
Primary outcome: Primary: Ability of 18F-FSPG PET/CT to Discriminate Benign From Malignant Nodules — 0.706; 0.778; 0.731; 0.817 proportion, range 0 to 1, higher better
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Computed Tomography (Procedure); fluorodeoxyglucose F-18 (Radiation); Fluorine F 18 L-glutamate Derivative BAY94-9392 (Drug); Laboratory Biomarker Analysis (Other); Positron Emission Tomography (Procedure); Positron Emission Tomography (PET) (Procedure)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Vanderbilt-Ingram Cancer Center
- Primary completion
- Aug 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ability of 18F-FSPG PET/CT to Discriminate Benign From Malignant Nodules |
0.706; 0.778; 0.731; 0.817; 0.824; 0.667 | — |
| SECONDARY CD44 and xC- Expression Levels in Tissue Samples(0-3) |
2.6; 1 | — |
| SECONDARY Uptake of 18F-FSPG (Expressed in Maximal Standardized Uptake Value [SUV] Within the Tumor) |
0.8; 3.9 | — |
| SECONDARY Ability of 18F-FSPG PET/CT to Stage of Lung Cancer (Metastatic or Not) |
0.8; 0.857; 0.824; 0.871; 0.2; 0.286 | — |
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. 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.
Eligibility Criteria
Inclusion Criteria
- 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).
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT02448225). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.