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

Study Overview
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Brief Summary
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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).

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

Conditions
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Breast Cancer Recurrent

Intervention / Treatment
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* Radiation: Dual-time PET/CT (low-dose)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Dual-time PET/CT<br> | Radiation: Dual-time PET/CT (low-dose)<br>* 4 MBq/kg 18F-flour-deoxyglucose administered iv. PET/CT-scans performed 60 min and 180 min after injection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dual-time PET/CT, Breast cancer recurrence, Bone scintigraphy, CT thorax upper abdomen