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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dual-time PET/CT | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dual-time PET/CT (low-dose) | Radiation | 4 MBq/kg 18F-flour-deoxyglucose administered iv. PET/CT-scans performed 60 min and 180 min after injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Malene Hildebrandt, M.D. | Dept. Nuclear Medicine, Odense University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Nuclear Medicine, Odense University Hospital | Odense | Funen | 5000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31921443 | Derived | 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. | |
| 29743027 | Derived | 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. |
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