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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00934401
Recruitment Status : Withdrawn (poor accrual)
First Posted : July 8, 2009
Last Update Posted : July 11, 2016
Information provided by (Responsible Party):
Yusuf Menda, University of Iowa

Brief Summary:
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 or disease
Breast Neoplasms

Study Type : Observational
Actual Enrollment : 0 participants
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
Study Start Date : July 2009
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Uptake of FLT (SUV) within the tumor [ Time Frame: 20 mintues and 60 minutes post injection ]

Secondary Outcome Measures :
  1. Pathologic tumor response [ Time Frame: 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes 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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00934401

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

Responsible Party: Yusuf Menda, Associate Professor, University of Iowa Identifier: NCT00934401     History of Changes
Other Study ID Numbers: 200903755
First Posted: July 8, 2009    Key Record Dates
Last Update Posted: July 11, 2016
Last Verified: July 2016

Keywords provided by Yusuf Menda, University of Iowa:
fluorolabeled thymidine
breast cancer
Positron-Emission Mammography

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