Clinical Response to Chemotherapy With Fluoro-L-Thymidine With Positron Emission Tomography (FLT-PET)

Sponsor

M.D. Anderson Cancer Center (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT00880074

Collaborator

(none)

Enrollment

Location

Arm

173

Anticipated Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of this clinical research study is to learn if an imaging solution, [F-18]-fluoro-L-thymidine (FLT), when used with a positron emission tomography (PET) scan, can help doctors to better see changes in the growth of tumors in the body. Researchers want to learn if FLT-PET scans can show an early response to chemotherapy.

Condition or Disease	Intervention/Treatment	Phase
Advanced Cancers	Radiation: PET Scan Drug: FLT	N/A

Detailed Description

FLT-PET Scan:

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

16 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Apr 1, 2009

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

Sep 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: FLT-PET Scan FLT solution is administered through a peripheral intravenous catheter approximately 60 minutes before the PET scan. 3 Positron Emission Tomography (PET) scans performed 60-90 minutes after intravenous injection of FLT: 1) within 2 weeks before day 1 of chemotherapy treatment; 2) day 6-7 of chemotherapy treatment; and,3) at end of chemotherapy treatment, day 19-20.	Radiation: PET Scan 3 Positron Emission Tomography (PET) scans performed 60-90 minutes after intravenous injection of FLT: 1) within 2 weeks before day 1 of chemotherapy treatment; 2) day 6-7 of chemotherapy treatment; and,3) at end of chemotherapy treatment, day 19-20. Other Names: Positron emission tomography Drug: FLT FLT solution is administered through a peripheral intravenous catheter approximately 60 minutes before the PET scan. Dosage of FLT in the range between 1 and 10 mCi. Other Names: [18F] fluorothymidine (FLT)

Arm

Intervention/Treatment

Experimental: FLT-PET Scan

FLT solution is administered through a peripheral intravenous catheter approximately 60 minutes before the PET scan. 3 Positron Emission Tomography (PET) scans performed 60-90 minutes after intravenous injection of FLT: 1) within 2 weeks before day 1 of chemotherapy treatment; 2) day 6-7 of chemotherapy treatment; and,3) at end of chemotherapy treatment, day 19-20.

Radiation: PET Scan

3 Positron Emission Tomography (PET) scans performed 60-90 minutes after intravenous injection of FLT: 1) within 2 weeks before day 1 of chemotherapy treatment; 2) day 6-7 of chemotherapy treatment; and,3) at end of chemotherapy treatment, day 19-20.

Other Names:

Positron emission tomography

Drug: FLT

FLT solution is administered through a peripheral intravenous catheter approximately 60 minutes before the PET scan. Dosage of FLT in the range between 1 and 10 mCi.

Other Names:

[18F] fluorothymidine (FLT)

Outcome Measures

Primary Outcome Measures

Response to Chemotherapy Shown in FLT-PET Scans [Baseline, Acute phase (Day 6-7), and Chronic phase (Day 19-20)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.
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.
Ability to understand and the willingness to sign a written informed consent document.
Participants must be 18 years of age or older.
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.