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

NCT ID: NCT01015131

Last Updated: 2021-02-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-08

Study Completion Date

2011-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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All Participants

18F-FLT-PET imaging

Group Type EXPERIMENTAL

18F-FLT-PET/CT Imaging

Intervention Type RADIATION

Participants receive the investigational radiotracer 18F-FLT intravenously and undergo Positron Emission Tomography (PET)/Computed Tomography (CT) scans at the following three times: prior to initiation of chemotherapy, at the end of the first cycle of treatment, and at the conclusion of chemotherapy.

Interventions

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18F-FLT-PET/CT Imaging

Participants receive the investigational radiotracer 18F-FLT intravenously and undergo Positron Emission Tomography (PET)/Computed Tomography (CT) scans at the following three times: prior to initiation of chemotherapy, at the end of the first cycle of treatment, and at the conclusion of chemotherapy.

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Other Identifiers

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2009_692

Identifier Type: OTHER

Identifier Source: secondary_id

0000-139

Identifier Type: -

Identifier Source: org_study_id

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