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Positron Emission Mammography With 3'-Deoxy-3'-[18F] Fluorothymidine (FLT PEM) for Evaluation of Response to Neoadjuvant Chemotherapy in Breast Cancer


N/A
18 Years
N/A
Not Enrolling
Female
Breast Neoplasms

Thank you

Trial Information

Positron Emission Mammography With 3'-Deoxy-3'-[18F] Fluorothymidine (FLT PEM) for Evaluation of Response to Neoadjuvant Chemotherapy in Breast Cancer


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.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Uptake of FLT (SUV) within the tumor

Outcome Time Frame:

20 mintues and 60 minutes post injection

Safety Issue:

No

Principal Investigator

Yusuf Menda, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

The University of Iowa Hospitals & Clinics

Authority:

United States: Food and Drug Administration

Study ID:

200903755

NCT ID:

NCT00934401

Start Date:

July 2009

Completion Date:

May 2010

Related Keywords:

  • Breast Neoplasms
  • FLT
  • fluorolabeled thymidine
  • breast cancer
  • Positron-Emission Mammography
  • Breast Neoplasms
  • Neoplasms

Name

Location

The University of Iowa Hospitals & Clinics PET CenterIowa City, Iowa  52242