Breast Cancer Recurrence - the Accuracy of Dual-time PET/CT (BREAC-AUT)
This study is currently recruiting participants.
Verified March 2012 by Odense University Hospital
Sponsor:
Odense University Hospital
Information provided by (Responsible Party):
Kirsten Falch, Odense University Hospital
ClinicalTrials.gov Identifier:
NCT01552655
First received: February 28, 2012
Last updated: March 9, 2012
Last verified: March 2012
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | February 28, 2012 | ||||||||
| Last Updated Date | March 9, 2012 | ||||||||
| Start Date ICMJE | December 2011 | ||||||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Diagnostic value of dual-time point 18FDG PET/CT in recurrent breast cancer [ Time Frame: 2 years ] [ Designated as safety issue: No ] 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. |
||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01552655 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Diagnostic value of early and late 18FDG PET/CT respectively in recurrent breast cancer [ Time Frame: 2 years ] [ Designated as safety issue: No ] 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. |
||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Breast Cancer Recurrence - the Accuracy of Dual-time PET/CT | ||||||||
| Official Title ICMJE | Breast Cancer Recurrence - the Accuracy of Dual-time PET/CT | ||||||||
| 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). |
||||||||
| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Investigator) Primary Purpose: Diagnostic |
||||||||
| Condition ICMJE | Breast Cancer Recurrent | ||||||||
| Intervention ICMJE | Radiation: Dual-time PET/CT (low-dose)
4 MBq/kg 18F-flour-deoxyglucose administered iv. PET/CT-scans performed 60 min and 180 min after injection. |
||||||||
| Study Arm (s) | Dual-time PET/CT
Intervention: Radiation: Dual-time PET/CT (low-dose) |
||||||||
| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 150 | ||||||||
| Estimated Completion Date | December 2013 | ||||||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Gender | Female | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
|
||||||||
| Location Countries ICMJE | Denmark | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01552655 | ||||||||
| Other Study ID Numbers ICMJE | BREAC-AUT | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Kirsten Falch, Odense University Hospital | ||||||||
| Study Sponsor ICMJE | Odense University Hospital | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
|
||||||||
| Information Provided By | Odense University Hospital | ||||||||
| Verification Date | March 2012 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||