Positron Emission Tomography in Monitoring Treatment Response in Women With Newly Diagnosed Breast Cancer

NCT01018251 | Withdrawn DMC

• 1 other identifier: UPCC 01109
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will investigate the sensitivity and specificity of FLT-PET/CT in primary breast cancer detection and in the use of FLT-PET in monitoring how well a breast tumor respond to treatment. We will compare this technique with other imaging modalities as well as with tissue collection (during a biopsy). We will recruit women with a newly diagnosed invasive breast cancer, who are able to tolerate undergoing a PET/CT (possibly two scans) scan,

Conditions

Adult Women With a New Diagnosis of Invasive Breast Cancer (Have Not Undergone Treatment)

Outcome Measures

Primary Outcomes (2)

• Sensitivity and specificity of FLT-PET comparing with standard FDG-PET

• Correlate SUV with % Ki67 nuclear stain

Secondary Outcomes (2)

• Change in SUV with change in tumor proliferation index (%Ki67 nuclear stain) (when neoadjuvant therapy is used)

• Tumor volume pre and post chemotherapy as assessed by clinical exam, breast imaging studies, histopathological examination, and breast cancer outcome parameters (when neoadjuvant therapy is used)

Study Arms (1)

Arm I

EXPERIMENTAL

Patients undergoing definitive surgery after cancer diagnosis undergo 3'-deoxy-3'-\[18F\] fluorothymidine (FLT)-PET prior to definitive surgery. Patients undergoing neoadjuvant chemotherapy prior to definitive surgery undergo FLT-PET prior to and after completion of neoadjuvant chemotherapy

Other: 3'-deoxy-3'-[18F]fluorothymidine; Procedure: Positron Emission Tomography/computed tomography; Radiation: FLT-PET/CT

Interventions

3'-deoxy-3'-[18F]fluorothymidine OTHER

Given IV

Also known as: 18F-FLT

Arm I

Positron Emission Tomography/computed tomography PROCEDURE

Arm I

FLT-PET/CT RADIATION

Arm I

Eligibility Criteria

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

You may qualify if:

• Breast biopsy positive for an invasive malignancy (core needle, mammatone, or incisional biopsy)
• Participants must be planning to have surgery at the Hospital of the University of Pennsylvania
• Participants must be able to tolerating lying on the table for about an hour
• Newly diagnosed primary breast cancer, which is classified as being operable (T1-T4)

You may not qualify if:

• Pregnant women
• History of severe renal disease
• Prior history of breast cancer of the study breast within the last five years.

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

MeSH Terms

Interventions

alovudine; Magnetic Resonance Spectroscopy

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 18, 2009
• First Posted: November 23, 2009
• Study Start: March 1, 2009
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: December 15, 2015

Record last verified: 2015-12