FLT-PET in Predicting Response to Chemotherapy in Patients With Advanced Malignancies

NCT00880074 | Completed Phase 1 FDA Drug

• 3 other identifiers: 2008-0106NCI-2012-01625NCI-2010-01046
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial studies fluorine F-18 fluorothymidine (FLT)-positron emission tomography (PET) in predicting response to chemotherapy in patients with advanced malignancies. FLT solution can help locate cancer cells inside the body. Diagnostic procedures, such as FLT-PET, may help find tumors and measure a patient's response to treatment.

Conditions

Malignant Neoplasm

Outcome Measures

Primary Outcomes (1)

• Response to Chemotherapy Shown in FLT-PET Scans

  through study completion; an average of 1 year.

Study Arms (1)

Diagnostic (fluorine F-18 fluorothymidine PET)

EXPERIMENTAL

Patients undergo fluorine F-18 fluorothymidine PET at baseline, at day 6-8 of course 1, day 20 of course 2, and prior to day 1 of course 3.

Drug: Fluorothymidine F-18; Other: Laboratory Biomarker Analysis; Procedure: Positron Emission Tomography

Interventions

Fluorothymidine F-18 DRUG

Undergo fluorine F-18 fluorothymidine PET

Also known as: 18F-FLT, 3'-Deoxy-3'-(18F) Fluorothymidine, 3'-deoxy-3'-[18F]fluorothymidine, ALOVUDINE F-18, Fluorothymidine F 18

Diagnostic (fluorine F-18 fluorothymidine PET)

Laboratory Biomarker Analysis OTHER

Optional correlative studies

Diagnostic (fluorine F-18 fluorothymidine PET)

Positron Emission Tomography PROCEDURE

Undergo fluorine F-18 fluorothymidine PET

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging, PT

Diagnostic (fluorine F-18 fluorothymidine PET)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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
• 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
• Pregnant or breast-feeding women
• History of hypersensitivity to 3'-deoxy-3'-18F-fluorothymidine (18F-FLT) or any component of the formulation

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• M D Anderson Cancer Center

MeSH Terms

Conditions

Neoplasms

Interventions

alovudine; Magnetic Resonance Spectroscopy

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Sarina A Piha-Paul

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2009
• First Posted: April 13, 2009
• Study Start: April 9, 2009
• Primary Completion: February 4, 2022
• Study Completion: February 4, 2022
• Last Updated: June 26, 2023

Record last verified: 2023-06

Locations

US (1)