This trial studies how well fluorine F 18 ISO-1 positron emission tomography (PET)/computed tomography (CT) imaging works in measuring sigma 2 receptor expression in patients with breast cancer that has spread to other places in the body. Sigma-2 receptors are substances found in some breast cancers and may be involved in making tumors divide. Fluorine F 18 ISO-1 PET/CT imaging may be able to detect whether or not tumors contain sigma receptors and may help doctors determine the best therapy for breast cancer patients in the future.
Additional locations may be listed on ClinicalTrials.gov for NCT03057743.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVES:
I. Correlate baseline and change in fluorine F 18 ISO-1 ([18F]ISO-1) uptake with progression free survival.
SECONDARY OBJECTIVES:
I. Correlate [18F]ISO-1 uptake with pathologic assays measuring cellular proliferation (e.g. Ki-67, TK1, mitotic index)
II. Correlate [18F]ISO-1 uptake with outcomes (e.g. overall survival).
III. Test the association of [18F]ISO-1 uptake with phenotypic breast cancer subtypes (e.g. HER2+, triple negative [TN], estrogen receptor [ER]/progesterone receptor [PR]+, etc.)
IV. Evaluate [18F]ISO-1 uptake at the time of clinical progression of disease.
OUTLINE:
Patients receive fluorine F 18 ISO-1 intravenously (IV) and undergo PET/CT imaging over 3 hours before starting new systemic therapy and approximately 3-6 weeks after starting new systemic therapy. Patients with clinical progression of disease, may receive additional fluorine F 18 ISO-1 IV and undergo PET/CT imaging.
After completion of study, patients are followed at 6 and 12 months and then periodically thereafter.
Trial PhaseNo phase specified
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationUniversity of Pennsylvania/Abramson Cancer Center
Principal InvestigatorElizabeth S. McDonald
