Positron Emission Mammography With Fluorothymidine (FLT) to Evaluate Treatment Response to Chemotherapy in Breast Cancer

Breast Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00934401
• Other study ID #: 200903755
• Status: Withdrawn
• Phase: N/A
• First received: July 6, 2009
• Last updated: July 7, 2016
• Start date: July 2009
• Est. completion date: May 2010

Study information

• Verified date: July 2016
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 100 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Neoplasms

Locations

Country	Name	City	State
United States	The University of Iowa Hospitals & Clinics PET Center	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
University of Iowa

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Uptake of FLT (SUV) within the tumor		20 mintues and 60 minutes post injection	No
Secondary	Pathologic tumor response		3 months	No