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FDG PET/CT in Breast Cancer Bone Mets

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01996046
Recruitment Status : Active, not recruiting
First Posted : November 27, 2013
Last Update Posted : August 14, 2020
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

Brief Summary:
This study will evaluate baseline uptake on a FDG PET/CT scan in patients with breast cancer that has spread to the bones. A repeat FDG PET/CT scan will be done 4 weeks after the start of new breast cancer hormone treatment and again at 12 weeks after treatment start. The baseline uptake and change in uptake after the repeat scans will be compared to clinical long term outcomes such as time to progression and overall survival. In addition the uptake will be compared to the incidence of skeletal related events that are common occurrences in patients with cancer that has spread to the bones.

Condition or disease Intervention/treatment
Estrogen Receptor Positive Breast Cancer Bone Metastases Other: FDG PET/CT scan

Detailed Description:
This is an observational study as all patients will receive the same research diagnostic test, an FDG PET/CT study performed at 4 weeks after starting new hormone treatment.

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Study Type : Observational
Estimated Enrollment : 75 participants
Observational Model: Case-Only
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
Study Start Date : September 2013
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Bone mets
Patients will undergo an [18F] FDG PET/CT scan at 4 weeks after starting new hormonal therapy
Other: FDG PET/CT scan
[18F] FDG PET/CT scan at 4 weeks after starting new hormonal therapy




Primary Outcome Measures :
  1. Progression free survival [ Time Frame: medical record reviewed every 6 months from date of enrollment to date of progression, up to 120 months ]
    Date of clinical progression will be recorded


Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: medical record reviewed every 6 months from date of enrollment to date of death, up to 120 months ]
    Date of death will be recorded


Other Outcome Measures:
  1. Number of patients who have a Skeletal Related Event [ Time Frame: medical record reviewed every 6 months from date of enrollment to date of death, up to 120 months ]
    Occurrence of radiation therapy to stabilize skeletal disease, pathologic fracture,spinal cord compression, surgery to stabilize the skeleton or hypercalcemia of malignancy will be recorded



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients with a history of ER+ breast cancer with documented bone metastases from breast cancer. Patients must be planning to start new hormone therapy for their breast cancer.
Criteria

Inclusion Criteria:

  1. Adult patients, at least 18 years of age, with a history of pathologically confirmed ER+ breast cancer
  2. Biopsy proven or clinically obvious documented bone metastases from breast cancer (with the majority of the disease burden in the bone)
  3. Patients planning to start new endocrine targeted therapy (any line of therapy is acceptable and any endocrine therapy is allowed)
  4. Willing and able to comply with scheduled visits and serial imaging procedures
  5. 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:

  1. Women who are pregnant or breast feeding
  2. Uncontrolled diabetes mellitus (fasting glucose greater than 200 mg/dL)
  3. Inability to tolerate imaging procedures (e.g. claustrophobia, severe pain)
  4. Weight exceeding capacity of imaging table
  5. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01996046


Locations
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United States, Pennsylvania
University of Pennsylvania Hospital
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Investigators
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Principal Investigator: David Mankoff, MD, PhD University of Pennsylvania
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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01996046    
Obsolete Identifiers: NCT02110160
Other Study ID Numbers: 817940
UPCC17113 ( Other Identifier: Penn cancer center )
First Posted: November 27, 2013    Key Record Dates
Last Update Posted: August 14, 2020
Last Verified: August 2020
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases