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18F-Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET/CT) For The Evaluation Of Response To Therapy In Bone-Dominant Metastatic Breast Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Abramson Cancer Center of the University of Pennsylvania
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT02110160
First received: April 8, 2014
Last updated: April 9, 2014
Last verified: April 2014

April 8, 2014
April 9, 2014
September 2013
September 2015   (final data collection date for primary outcome measure)
Number of Adverse Events [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT02110160 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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18F-Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET/CT) For The Evaluation Of Response To Therapy In Bone-Dominant Metastatic Breast Cancer
18F-Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET/CT) For The Evaluation Of Response To Therapy In Bone-Dominant Metastatic Breast Cancer

The purpose of this study is to assess the utility of FDG PET/CT in evaluating response of bone dominant breast cancer to therapy. Eligible patients with bone dominant ER+ breast cancer will undergo baseline FDG PET/CT for evaluation of their disease, after the start of therapy they will undergo an FDG PET/CT scan at 4 weeks and again at 12 weeks. PET/CT results will be compared to clinical measures of response, time to progression and overall survival.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

A total of up to 75 subjects, age 18 years, with a diagnosis or estrogen receptor positive (ER+) breast cancer, with clinical evidence of bone dominant stage IV disease will be enrolled in this study. This study will enroll both women and men but it is anticipate that the majority of subjects will be women due to the small percentage of breast cancer patients that are male.

Bone Dominant Metastatic ER+ Breast Cancer
  • Device: FDG PET/CT
  • Biological: Fluorodeoxyglucose F 18 Injection (FDG)
patients with bone dominant metastatic ER+ breast cancer
Interventions:
  • Device: FDG PET/CT
  • Biological: Fluorodeoxyglucose F 18 Injection (FDG)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
75
September 2015
September 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult patients, at least 18 years of age, with a history of pathologically confirmed ER+ breast cancer
  • Biopsy proven or clinically obvious documented bone metastases from breast cancer (with the majority of the disease burden in the bone)
  • Patients planning to start new endocrine targeted therapy (any line of therapy is acceptable and any endocrine therapy is allowed)
  • Willing and able to comply with scheduled visits and serial imaging procedures
  • Agrees to allow access to clinical records regarding response to treatment and long term follow up 6. Be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines.

Exclusion Criteria

  • Women who are pregnant or breast feeding
  • Uncontrolled diabetes mellitus (fasting glucose greater than 200 mg/dL)
  • Inability to tolerate imaging procedures (e.g. claustrophobia, severe pain)
  • Weight exceeding capacity of imaging table
  • Previous treatment with radiation or surgery to a significant percentage of bony metastatic sites 6. Treatment with marrow stimulating agents (e.g. granulocyte colony stimulating factor (GCSF)) within 3 weeks of baseline scan
Both
18 Years and older
No
Contact: David A. Mankoff, MD 855-216-0098 PennCancerTrials@emergingmed.com
United States
 
NCT02110160
UPCC 17113
Yes
Abramson Cancer Center of the University of Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Not Provided
Principal Investigator: David Mankoff, MD Abramson Cancer Center of the University of Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
April 2014

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