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
  Purpose

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.


Condition Intervention
Bone Dominant Metastatic ER+ Breast Cancer
Device: FDG PET/CT
Biological: Fluorodeoxyglucose F 18 Injection (FDG)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 18F-Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET/CT) For The Evaluation Of Response To Therapy In Bone-Dominant Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by Abramson Cancer Center of the University of Pennsylvania:

Primary Outcome Measures:
  • Number of Adverse Events [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 75
Study Start Date: September 2013
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
patients with bone dominant metastatic ER+ breast cancer Device: FDG PET/CT Biological: Fluorodeoxyglucose F 18 Injection (FDG)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02110160

Contacts
Contact: David A. Mankoff, MD 855-216-0098 PennCancerTrials@emergingmed.com

Locations
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: David Mankoff, MD    855-216-0098    PennCancerTrials@emergingmed.com   
Principal Investigator: David Mankoff, MD         
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
Investigators
Principal Investigator: David Mankoff, MD Abramson Cancer Center of the University of Pennsylvania
  More Information

No publications provided

Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02110160     History of Changes
Other Study ID Numbers: UPCC 17113
Study First Received: April 8, 2014
Last Updated: April 9, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Fluorodeoxyglucose F18
Deoxyglucose
Radiopharmaceuticals
Diagnostic Uses of Chemicals
Pharmacologic Actions
Molecular Mechanisms of Pharmacological Action
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 21, 2014