TheranosticTrials.org

Clinical Trial · NCT02448225

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

Overview

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.

Sponsor

Vanderbilt-Ingram Cancer Center

Phase

Phase 2

Contacts

Chirayu Shah, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT02448225

Drug / Compound

FDG

Isotope(s):
Target(s):
  • Glucose Transport
Ligand Class: Small Molecules

FSPG

Isotope(s):
Target(s):
  • Cystine/glutamate antiporter
Ligand Class: Small Molecules

Eligibility

Inclusion

  • 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).
  • Have a newly diagnosed, untreated primary lung cancer diameter 7 mm or more.
  • \- 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

Exclusion

  • 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
  • For patients who do not have a tissue diagnosis:
  • Previous systemic or radiation treatment for cancer of any type within 1 year
  • 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.