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Clinical Trial · NCT00968409
Assessment of Progesterone Receptors in Breast Carcinoma by Positron Emission Tomography (PET) Using Fluoro Furanyl Norprogesterone (FFNP)
Overview
The purpose of this study is to see if Positron Emission Tomography (PET) imaging with a radioactive form of the hormone progesterone called FFNP will give the same results as hormone receptor testing already performed on tissue used to diagnose breast cancer.
Sponsor
Washington University School of Medicine
Phase
Phase 1
Contacts
Farrokh Dehdashti, M.D. (PRINCIPAL_INVESTIGATOR)
ClinicalTrials.gov
NCT00968409Drug / Compound
FFNP
Isotope(s):
FLUORINE-18
Radioisotope: F-18
Theranostic Role: PET Imaging
T1/2 (Half-Life): 1.8 Hours
Decay Mode: POSITRON β+ (96.7%), ELECTRON CAPTURE (3.3%), GAMMA 511 keV
Energy: Eβ+ 635 keV
Range: N/A
Decay Daughters: O18 (Stable)
Status: FDA Approvals: FDG (Cancer 2005): GLUDEF®, METATRACE® AXUMIN® (2016), PYLARIFY® (2023), POSLUMA® (2024)
Target(s):
- Estrogen Receptor
Ligand Class: Small Molecules
FFNP
Isotope(s):
FLUORINE-18
Radioisotope: F-18
Theranostic Role: PET Imaging
T1/2 (Half-Life): 1.8 Hours
Decay Mode: POSITRON β+ (96.7%), ELECTRON CAPTURE (3.3%), GAMMA 511 keV
Energy: Eβ+ 635 keV
Range: N/A
Decay Daughters: O18 (Stable)
Status: FDA Approvals: FDG (Cancer 2005): GLUDEF®, METATRACE® AXUMIN® (2016), PYLARIFY® (2023), POSLUMA® (2024)
Target(s):
- Progesterone
Ligand Class: Small Molecules
Eligibility
Inclusion
- Not currently pregnant or nursing: Subject must be surgically sterile (has had a documented bilateral oophorectomy and / or documented hysterectomy), post menopausal (cessation of menses for more than 1 year), non lactating, or of childbearing potential for whom a urine pregnancy test (with the test performed within the 24 hour period immediately prior to administration of FFNP) is negative.
- Biopsy-proven breast cancer
- Primary lesion size ≥ 1.5 cm as determined by imaging studies (ultrasonography, mammography, CT or MRI) or physical examination
- Tumor estrogen-receptor and progesterone-receptor status already determined or scheduled to be determined at time of surgery without intervening therapy.
Exclusion
- Unable to tolerate 60-90 minutes of PET imaging per imaging session
- No previous history of hormone therapy; NOTE - subjects who were treated with hormone therapy for reasons other than breast cancer or breast cancer prevention may be allowed to participate after review of history by the primary investigator
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