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NCT Number: NCT01627704

Fluoroestradiol PET Imaging in Predicting Response to Hormone Therapy of 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.

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Key information

Conditions

Metastatic Breast Cancer Breast Diseases Breast Neoplasms Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Service de Médecine Nucléaire, Hôpital Tenon

Paris, 75020, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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  • Treated by antihormone treatment during around 5 years withdrawn for at least 3 months OR metastatic cancer at diagnosis having received no more than one line of hormone treatment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)

Treatment and study plan

Fluoroestradiol (18F)

Drug

2-4 MBq/kg body mass, one single IV injection

Primary outcomes

  1. Response rate six months after induction or major change in hormone therapy for metastatic breast cancer.

    Time frame: at 6 months

    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.

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

16α-[18F]-Fluoro-œstradiol PET: an in Vivo Biomarker Predicting Response to Hormone Treatment of Metastatic Breast Cancer?

Acronym: ESTROTEPREDIC

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jun 26, 2012
Registry last updated
Oct 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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