Trial record 1 of 1 for:    NCT00934401
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Positron Emission Mammography With Fluorothymidine (FLT) to Evaluate Treatment Response to Chemotherapy in Breast Cancer

This study has been terminated.
(poor accrual)
Sponsor:
Information provided by:
University of Iowa
ClinicalTrials.gov Identifier:
NCT00934401
First received: July 6, 2009
Last updated: June 1, 2010
Last verified: June 2010
  Purpose

Positron Emission Tomography Imaging with 3-Deoxy-3'-[18F]Fluorothymidine (FLT) can selectively identify proliferating and non-proliferating tissues, including tumors. FLT uptake in the tumor is an indirect marker of DNA synthesis activity, which is a target of chemotherapy. Our hypothesis is that early change in FLT uptake in tumor with chemotherapy will predict pathological response to neoadjuvant therapy in breast cancer. Tumor uptake of FLT will be imaged and measured with positron emission mammography (PEM), a PET scanner optimized for breast imaging with a significantly improved resolution compared to conventional whole-body PET imaging systems.


Condition
Breast Neoplasms

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Positron Emission Mammography With 3'-Deoxy-3'-[18F] Fluorothymidine (FLT PEM) for Evaluation of Response to Neoadjuvant Chemotherapy in Breast Cancer

Resource links provided by NLM:


Further study details as provided by University of Iowa:

Primary Outcome Measures:
  • Uptake of FLT (SUV) within the tumor [ Time Frame: 20 mintues and 60 minutes post injection ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pathologic tumor response [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: July 2009
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Women diagnosed with breast cancer whose recommended treatment is neoadjuvant chemotherapy followed by surgical resection.

Criteria

Inclusion Criteria:

  1. Ability to understand and willingness to sign a written informed consent document.
  2. Subject must have histologically confirmed breast cancer.
  3. Subject must be scheduled to receive neoadjuvant chemotherapy followed by surgery for their standard cancer care. Treatment decisions will be made by the treating surgeon and the medical oncologist.
  4. Females at least 18 years of age.
  5. Karnofsky at least 60% at time of screening.
  6. Life expectancy of greater than 6 months.
  7. Subject must have normal organ and marrow function (as defined below) within 30 days of study enrollment:

    • leukocytes at least 3,000/microL
    • absolute neutrophil count at least 1,500/microL
    • platelets at least 100,000/microL
    • total bilirubin Equal or less than 1.0 mg/dl
    • AST(SGOT) no greater than 2.5 X institutional upper limit of normal
    • ALT (SGPT) no greater than 2.5 X institutional upper limit of normal
    • Creatinine Equal or less than 1.4 mg/dl
    • BUN Equal or less than 20 mg /dl
  8. The effects of FLT on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. A screening urine hCG will be administered in the Nuclear Medicine to women of childbearing potential before each FLT scan and pregnant women will not be accepted as subjects in this study.

Exclusion Criteria:

  1. Subjects who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
  2. Subject with a Karnofsky score of below 60.
  3. Pregnant women are excluded from this study. FLT PET has potential for teratogenic effects. Because there are potentially unknown risks for adverse events in nursing infants secondary to treatment of the mother with FLT, breastfeeding should be discontinued if the mother is imaged with FLT and may not resume for 48 hours after the FLT imaging.
  4. Subjects taking nucleoside analog medications such as those used as antiretroviral agents.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00934401

Locations
United States, Iowa
The University of Iowa Hospitals & Clinics PET Center
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
University of Iowa
Investigators
Principal Investigator: Yusuf Menda, M.D. The University of Iowa Hospitals & Clinics
  More Information

No publications provided

Responsible Party: Yusuf Menda, M.D., The University of Iowa
ClinicalTrials.gov Identifier: NCT00934401     History of Changes
Other Study ID Numbers: 200903755
Study First Received: July 6, 2009
Last Updated: June 1, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Iowa:
FLT
fluorolabeled thymidine
breast cancer
Positron-Emission Mammography

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on April 17, 2014