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Early Prediction of Clinical Response to Chemotherapy With FLT-PET {[F-18]-Fluoro-L-thymidine (FLT) With Positron Emission Tomography (PET)}

18 Years
Open (Enrolling)
Advanced Cancers

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Trial Information

Early Prediction of Clinical Response to Chemotherapy With FLT-PET {[F-18]-Fluoro-L-thymidine (FLT) With Positron Emission Tomography (PET)}


A FLT-PET scan uses the FLT solution, which contains a small amount of radioactive material,
to help locate cancer cells inside the body. This scan may help doctors find solid tumors
as well as learn if these tumors are growing and how fast they are growing. This
information could be used to help predict if the cancer will respond to treatment.

Study Visits:

Within 2 weeks before Day 1 of Cycle 1, on Day 6, 7, or 8 of Cycle 1, and within 2 days of
Day 20 of Cycle 2, you will have a FLT-PET scan.

For at least 4 hours before the FLT-PET scan, you must not eat or drink anything. You will
receive the FLT solution through a peripheral intravenous catheter. The FLT solution is a
mildly radioactive material. The radioactive nature of the solution allows the scanner to
"see" it in certain places in your body. After the injection, you will need to rest quietly
until it is time for the scan. The amount of rest time may vary, but be prepared to wait
for about 60 minutes. During the scan, you will lie flat on your back on a table. After the
solution is injected into a vein, the PET scanner takes pictures of the radioactive solution
as it moves through the body and collects at various sites in the body. By watching how the
solution travels through the body and studying where the solution collects, researchers can
learn the extent of disease in the body. The scan itself may last about 40-60 minutes.

Your vital signs (blood pressure, heart rate, temperature, and breathing rate) will be
measured before each injection of the FLT solution, 30 minutes after each injection, before
each PET scan, and 3 times after each PET scan.

Length of Study:

You will be off this study after the third FLT-PET scan. You will be taken off study if you
experience intolerable side effects or the study doctor thinks it is in your best interest.

This is an investigational study. The FLT solution is not FDA approved or commercially
available. At this time, FLT solution is only being used in research.

Up to 16 patients will take part in this study. All will be enrolled at MD Anderson.

Inclusion Criteria:

1. Patients actively enrolled and being treated on Protocol 2007-0668: Combination
Therapy with Bevacizumab and Temsirolimus in Patients with Advanced Malignancy at
M.D. Anderson Cancer Center. These patients must have met the inclusion and exclusion
criteria for that protocol. For details please see Appendix G.

2. Women of child-bearing potential (as defined as women who are not post-menopausal for
12 months or who have had no previous surgical sterilization) and men must agree to
use adequate contraception (hormonal or barrier method of birth control; abstinence)
prior to study entry, for the duration of study participation, and for 90 days after
the last dose.

3. Ability to understand and the willingness to sign a written informed consent

4. Participants must be 18 years of age or older.

5. Patient actively enrolled and being treated on Protocol 2012-0061 "A Phase I Trial of
Bevacizumab, Temsirolimus Alone and in Combination with Valproic Acid or Cetuximab in
Patients with Advanced Malignancy" at M.D. Anderson Cancer Center.

Exclusion Criteria:

1. Pregnant or breast-feeding women.

2. History of hypersensitivity to 3'-deoxy-3'-18F-fluorothymidine (18F-FLT) or any
component of the formulation.

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Response to Chemotherapy Shown in FLT-PET Scans

Outcome Time Frame:

Baseline, Acute phase (Day 6-7), and Chronic phase (Day 19-20)

Safety Issue:


Principal Investigator

Sarina Piha-Paul, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

April 2009

Completion Date:

Related Keywords:

  • Advanced Cancers
  • Advanced Cancers
  • Positron Emission Tomography
  • PET
  • [18F] fluorothymidine
  • [F-18]-fluoro-L-thymidine
  • FLT
  • Neoplasms



UT MD Anderson Cancer CenterHouston, Texas  77030