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Clinical Trial · NCT01627704
Fluoroestradiol PET Imaging in Predicting Response to Hormone Therapy of Breast Cancer
Overview
Compare the response rate after 6 months of hormone treatment (or a major change in hormone treatment) in metastatic breast cancer, according to the uptake of FES in metastatic lesions taking-up FDG on PET/CT at baseline. Hypothesis: best response rate will be observed in patients with all metastases taking up FES prior to treatment.
Sponsor
Assistance Publique - Hôpitaux de Paris
Phase
N/A
Contacts
Khaldoun KERROU, MD (PRINCIPAL_INVESTIGATOR)
ClinicalTrials.gov
NCT01627704Drug / Compound
fluoroestradiol
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
Eligibility
Inclusion
- Metastatic adenocarcinoma of the breast
- WHO 0-2
- Life expectancy \> 6 months
- Post menopausal
- FDG PET/CT available on PACS or CD DICOM III format 11
- Treated by antihormone treatment during around 5 years withdrawn for at least 3 months OR metastatic cancer at diagnosis having received no more than one line of hormone treatment
- Presence of oestrogen receptors proven with immunohistochemistry (\> 10%) and HER2 determined by immunohistochemistry or FISH (on primary tumour or a metastasis)
- Metastatic recurrence on FDG PET dating less than 1 month, confirmed by another modality (contrast-enhanced CT, MRI, ultrasonography, bone scintigraphy or PET/CT, other)
- Hormone-dependent cancer initially demonstrated by hormone receptors in the tumour
Exclusion
- Isolated liver metastasis (high FES uptake by normal liver)
- Other evolutive malignant disease or acute or chronic infectious disease
- Chemotherapy during the last 3 months or change in treatment since FDG PET/CT.
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