Fluoroestradiol PET Imaging in Predicting Response to Hormone Therapy of Breast Cancer (ESTROTEPREDIC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01627704
First received: June 14, 2012
Last updated: September 6, 2012
Last verified: September 2012

June 14, 2012
September 6, 2012
June 2012
June 2014   (final data collection date for primary outcome measure)
Response rate six months after induction or major change in hormone therapy for metastatic breast cancer. [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
Response rate six months after induction or major change in hormone therapy for metastatic breast cancer. Response will be determined according to RECIST 1.1 criteria for each patient.
Same as current
Complete list of historical versions of study NCT01627704 on ClinicalTrials.gov Archive Site
Number of visible non-physiologic foci on FES PET and on the corresponding FDG PET, during centralised reading sessions by masked readers. [ Time Frame: at 6 months ] [ Designated as safety issue: Yes ]
Determination of a standard of truth on the extent of the disease at baseline, by independent assessor on basis of imaging except FES and FDG PET/CT. [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Fluoroestradiol PET Imaging in Predicting Response to Hormone Therapy of Breast Cancer
16α-[18F]-Fluoro-œstradiol PET: an in Vivo Biomarker Predicting Response to Hormone Treatment of Metastatic Breast Cancer?

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.

Main objective: 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.

Secondary objectives:

  • evaluate diagnostic performance of FES PET/CT
  • determine whether FES PET/CT is able to detect metastases that are not visible on FDG PET/CT. This point may constitute a direct benefit for the patient
  • precise the nature of discordant FES/FDG foci
  • validate and improve the interpretation criteria for FES PET/CT
  • confirm the perfect tolerance
Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Metastatic Breast Cancer
Drug: Fluoroestradiol (18F)
2-4 MBq/kg body mass, one single IV injection
Fluoroestradiol (18F)
NA
Intervention: Drug: Fluoroestradiol (18F)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
72
June 2015
June 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Post menopausal
  • age > 17
  • WHO 0-2
  • Metastatic adenocarcinoma of the breast
  • 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
  • Life expectancy > 6 months
  • Hormone-dependent cancer initially demonstrated by hormone receptors in the tumour
  • 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)
  • FDG PET/CT available on PACS or CD DICOM III format 11
  • Informed consent obtained

Exclusion Criteria:

  • Other evolutive malignant disease or acute or chronic infectious disease
  • Chemotherapy during the last 3 months or change in treatment since FDG PET/CT.
  • Isolated liver metastasis (high FES uptake by normal liver)
Female
18 Years and older
No
Contact: Khaldoun KERROU, MD 33 1 56 01 67 98 Khaldoun.kerrou@tnn.aphp.fr
Contact: Jean-Noël TALBOT, MD-PHD Jean-noel.talbot@tnn.aphp.fr
France
 
NCT01627704
P110113, IDRCB
No
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: Khaldoun KERROU, MD Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP