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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00880074
First received: April 9, 2009
Last updated: May 12, 2014
Last verified: May 2014
  Purpose

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 Intervention
Advanced Cancers
Radiation: PET Scan
Drug: FLT

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)}

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Response to Chemotherapy Shown in FLT-PET Scans [ Time Frame: Baseline, Acute phase (Day 6-7), and Chronic phase (Day 19-20) ] [ Designated as safety issue: No ]

Estimated Enrollment: 16
Study Start Date: April 2009
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Positron emission tomography
Drug: FLT
FLT solution is administered through a peripheral intravenous catheter approximately 60 minutes before the PET scan.
Other Name: [18F] fluorothymidine (FLT)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 document.
  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00880074

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Sarina Piha-Paul, MD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00880074     History of Changes
Other Study ID Numbers: 2008-0106, NCI-2012-01625
Study First Received: April 9, 2009
Last Updated: May 12, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Advanced Cancers
FLT-PET
Positron Emission Tomography
PET
[18F] fluorothymidine
[F-18]-fluoro-L-thymidine
FLT

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on July 24, 2014