18F-FLT-PET in Breast Cancer (MK-0000-139)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 2

Conditions: Breast Cancer

Treatments: Radiation: 18F-FLT-PET/CT Imaging

Study type: Interventional

Funder types: Industry

Identifiers

NCT01015131

0000-139

2009_692 (Other Identifier)

Details and patient eligibility

About

This study correlated changes from baseline in Ki-67, an immunohistochemical marker of cell proliferation, with changes from baseline in tumor uptake of 3'-deoxy-3'[18F]-fluorothymidine (18F-FLT) following the first cycle of treatment with standard of care neo-adjuvant therapy in participants with breast cancer.

Enrollment: 46 patients

Sex: Female

Ages: 35 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Has newly-diagnosed stage IIB/IIIA/IIIB locally advanced breast cancer
• Is eligible for pre-operative (neo-adjuvant) chemotherapy

Exclusion criteria

• Has a contraindication to magnetic resonance imaging (MRI)
• Any condition that would limit ability to undergo MRI or PET scans
• Is a nursing mother
• Has moderate to end-stage renal disease and is not on dialysis or has renal failure on chronic dialysis

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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46 participants in 1 patient group

All Participants

Experimental group

Description:

18F-FLT-PET imaging

Treatment:

Radiation: 18F-FLT-PET/CT Imaging