- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01018251
Positron Emission Tomography in Monitoring Treatment Response in Women With Newly Diagnosed Breast Cancer
December 14, 2015 updated by: Abramson Cancer Center of the University of Pennsylvania
Monitoring Treatment Response in Women With Breast Cancer Utilizing FLT-PET/CT
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,
Study Overview
Status
Withdrawn
Conditions
Detailed Description
Our overall goal is to use this clinical trial as a platform to validate fibroblast activation protein (FAP) as a biomarker for the tumor microenvironment and to explore the dynamic interaction between proliferating tumor cells and the tumor microenvironment.
Our long term goal is to develop new drugs that will target the tumor microenvironment as novel therapeutic and chemoprevention strategies.
Study Type
Interventional
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- Pregnant women
- History of severe renal disease
- Prior history of breast cancer of the study breast within the last five years.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm I
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
|
Given IV
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Sensitivity and specificity of FLT-PET comparing with standard FDG-PET
|
Correlate SUV with % Ki67 nuclear stain
|
Secondary Outcome Measures
Outcome Measure |
---|
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)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2009
Primary Completion (Actual)
June 1, 2011
Study Completion (Actual)
June 1, 2011
Study Registration Dates
First Submitted
November 18, 2009
First Submitted That Met QC Criteria
November 19, 2009
First Posted (Estimate)
November 23, 2009
Study Record Updates
Last Update Posted (Estimate)
December 15, 2015
Last Update Submitted That Met QC Criteria
December 14, 2015
Last Verified
December 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UPCC 01109
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Adult Women With a New Diagnosis of Invasive Breast Cancer (Have Not Undergone Treatment)
-
Sanford HealthNational Ataxia Foundation; Beyond Batten Disease Foundation; Pitt Hopkins Research... and other collaboratorsRecruitingMitochondrial Diseases | Retinitis Pigmentosa | Myasthenia Gravis | Eosinophilic Gastroenteritis | Multiple System Atrophy | Leiomyosarcoma | Leukodystrophy | Anal Fistula | Spinocerebellar Ataxia Type 3 | Friedreich Ataxia | Kennedy Disease | Lyme Disease | Hemophagocytic Lymphohistiocytosis | Spinocerebellar Ataxia... and other conditionsUnited States, Australia
Clinical Trials on 3'-deoxy-3'-[18F]fluorothymidine
-
UNICANCERCompleted
-
Frederick Daniel GrantDana-Farber Cancer InstituteCompleted
-
National Taiwan University HospitalUnknownBreast CancerTaiwan
-
Hamad Medical CorporationUnknownEssential Thrombocythemia | Primary Myelofibrosis, Prefibrotic Stage | Primary Myelofibrosis, Fibrotic StageQatar
-
Hamad Medical CorporationTerminatedPolycythemia Vera | Essential Thrombocythemia | Primary Myelofibrosis, Prefibrotic Stage | Primary Myelofibrosis, Fibrotic StageQatar
-
UNC Lineberger Comprehensive Cancer CenterTerminatedGraft Vs Host DiseaseUnited States
-
Dana-Farber Cancer InstituteCompletedCervical Cancer | Vaginal Cancer | Uterine Cancer | Carcinoma of the VulvaUnited States
-
Barbara Ann Karmanos Cancer InstituteNational Cancer Institute (NCI)SuspendedLymphoma | Myelodysplastic Syndromes | Leukemia | Chronic Myeloproliferative Disorders | Brain and Central Nervous System Tumors | Unspecified Adult Solid Tumor, Protocol Specific | Multiple Myeloma and Plasma Cell Neoplasm | Lymphoproliferative Disorder | Myelodysplastic/Myeloproliferative NeoplasmsUnited States
-
National Cancer Institute (NCI)WithdrawnCarcinoma, Non-Small-Cell Lung | Thymus Neoplasms
-
Dana-Farber Cancer InstituteBrigham and Women's HospitalCompletedEsophageal CancerUnited States