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

NCT01552655 | Completed

• 1 other identifier: BREAC-AUT
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

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).

Conditions

Breast Cancer Recurrent

Keywords

Dual-time PET/CT; Breast cancer recurrence; Bone scintigraphy; CT thorax upper abdomen

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Diagnostic value of early and late 18FDG PET/CT respectively in recurrent breast cancer

  2 years

Study Arms (1)

Dual-time PET/CT

OTHER

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

Interventions

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.

Dual-time PET/CT

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Odense University Hospital: lead

Study Sites (1)

Department of Nuclear Medicine, Odense University Hospital

Odense, Funen, 5000, Denmark

Location

Related Publications (2)

• 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.

  PMID: 31921443 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.

  PMID: 29743027 DERIVED

Study Officials

• Malene Hildebrandt, M.D.

  Dept. Nuclear Medicine, Odense University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Technologist

Study Record Dates

• First Submitted: February 28, 2012
• First Posted: March 13, 2012
• Study Start: December 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: April 21, 2015

Record last verified: 2015-04

Locations

DK (1)