Clinical trial · Interventional
Breast Cancer Recurrence - the Accuracy of Dual-time PET/CT
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Recurrent | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dual-time PET/CT (low-dose) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Dual-time PET/CT
- interventionNames
- Radiation: Dual-time PET/CT (low-dose)
Primary outcomes (1)
- measure
- Diagnostic value of dual-time point 18FDG PET/CT in recurrent breast cancer
- timeFrame
- 2 years
- 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.
Secondary outcomes (1)
- measure
- Diagnostic value of early and late 18FDG PET/CT respectively in recurrent breast cancer
- timeFrame
- 2 years
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDVogsen 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. PMID 31921443
- DERIVEDBaun 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. PMID 29743027