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Breast Cancer Recurrence - the Accuracy of Dual-time PET/CT (BREAC-AUT)

Primary Purpose

Breast Cancer Recurrent

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Dual-time PET/CT (low-dose)
Sponsored by
Odense University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Cancer Recurrent focused on measuring Dual-time PET/CT, Breast cancer recurrence, Bone scintigraphy, CT thorax upper abdomen

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinical suspected recurrence of breast cancer
  • Blood glucose level less than 8,0 mmol/L

Exclusion Criteria:

  • Disqualified patients
  • Other malignancies
  • < 18 years
  • < 50 kg
  • > 90 kg
  • Pregnant or lactating
  • Patients with permanent address outside of the Region of Southern Denmark
  • Estimated inability to collaborate

Sites / Locations

  • Department of Nuclear Medicine, Odense University Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Dual-time PET/CT

Arm Description

Outcomes

Primary Outcome Measures

Diagnostic value of dual-time point 18FDG PET/CT in recurrent breast cancer
The sensitivity and specificity of dual-time point 18FDG PET/CT will be compared to conventional imaging modalities usually used in the work up of patients with suspected recurrent breast cancer. In this case CT of thorax and upper abdomen and bone scintigraphy.

Secondary Outcome Measures

Diagnostic value of early and late 18FDG PET/CT respectively in recurrent breast cancer
The sensitivity and specificity of early (60 min post injection) and late (180 min post injection) 18FDG PET/CT respectively in patients with suspected recurrent breast cancer.

Full Information

First Posted
February 28, 2012
Last Updated
April 20, 2015
Sponsor
Odense University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01552655
Brief Title
Breast Cancer Recurrence - the Accuracy of Dual-time PET/CT
Acronym
BREAC-AUT
Official Title
Breast Cancer Recurrence - the Accuracy of Dual-time PET/CT
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Odense University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to elucidate the value of dual-time-point PET/CT in the recurrence of breast cancer and to determine whether the method is better than the modalities used in the standard work up. 150 patients with suspected breast cancer recurrence will be included. All patients will undergo dual-time-point PET/CT, CT of thorax and upper abdomen and bone scintigraphy. After completion of the examinations the early and the late PET/CT scan will be compared with each other, the diagnostic CT-scan and the bone scintigraphy. A verification of suspicious findings will be done by biopsy, if the area is accessible. If a biopsy cannot be obtained, the presence of recurrence will be verified with additional imaging follow-up to ensure the highest possible confidence. Sensitivity, specificity, accuracy, negative and positive predictive value (NPV/PPV) will be calculated for each modality (incl. early and late PET/CT).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Recurrent
Keywords
Dual-time PET/CT, Breast cancer recurrence, Bone scintigraphy, CT thorax upper abdomen

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
N/A
Enrollment
101 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dual-time PET/CT
Arm Type
Other
Intervention Type
Radiation
Intervention Name(s)
Dual-time PET/CT (low-dose)
Intervention Description
4 MBq/kg 18F-flour-deoxyglucose administered iv. PET/CT-scans performed 60 min and 180 min after injection.
Primary Outcome Measure Information:
Title
Diagnostic value of dual-time point 18FDG PET/CT in recurrent breast cancer
Description
The sensitivity and specificity of dual-time point 18FDG PET/CT will be compared to conventional imaging modalities usually used in the work up of patients with suspected recurrent breast cancer. In this case CT of thorax and upper abdomen and bone scintigraphy.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Diagnostic value of early and late 18FDG PET/CT respectively in recurrent breast cancer
Description
The sensitivity and specificity of early (60 min post injection) and late (180 min post injection) 18FDG PET/CT respectively in patients with suspected recurrent breast cancer.
Time Frame
2 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical suspected recurrence of breast cancer Blood glucose level less than 8,0 mmol/L Exclusion Criteria: Disqualified patients Other malignancies < 18 years < 50 kg > 90 kg Pregnant or lactating Patients with permanent address outside of the Region of Southern Denmark Estimated inability to collaborate
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Malene Hildebrandt, M.D.
Organizational Affiliation
Dept. Nuclear Medicine, Odense University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Nuclear Medicine, Odense University Hospital
City
Odense
State/Province
Funen
ZIP/Postal Code
5000
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
31921443
Citation
Vogsen M, Geneser S, Rasmussen ML, Horder M, Hildebrandt MG. Learning from patient involvement in a clinical study analyzing PET/CT in women with advanced breast cancer. Res Involv Engagem. 2020 Jan 6;6:1. doi: 10.1186/s40900-019-0174-y. eCollection 2020.
Results Reference
derived
PubMed Identifier
29743027
Citation
Baun C, Falch K, Gerke O, Hansen J, Nguyen T, Alavi A, Hoilund-Carlsen PF, Hildebrandt MG. Quantification of FDG-PET/CT with delayed imaging in patients with newly diagnosed recurrent breast cancer. BMC Med Imaging. 2018 May 9;18(1):11. doi: 10.1186/s12880-018-0254-8.
Results Reference
derived

Learn more about this trial

Breast Cancer Recurrence - the Accuracy of Dual-time PET/CT

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