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Completed

NCT Number: NCT01552655

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

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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Key information

Conditions

Breast Cancer Recurrent

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Nuclear Medicine, Odense University Hospital

Odense, Funen, 5000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Diagnostic value of dual-time point 18FDG PET/CT in recurrent breast cancer

    Time frame: 2 years

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

    Time frame: 2 years

    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.

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Registry information

Acronym: BREAC-AUT

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Mar 13, 2012
Registry last updated
Apr 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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