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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-09

Study Completion Date

2022-02-04

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Phase II Study of Fluorine-18 3'-Deoxy-3'-Fluorothymidine (F-18-FLT) in Invasive Breast Cancer

NCT00572728

Stage IIB Breast Cancer Stage IIIA Breast Cancer Stage IIIB Breast Cancer +1 more

COMPLETED PHASE2

3'-Deoxy-3'-[18F] Fluorothymidine PET Imaging in Patients With Cancer

NCT00935090

Brain and Central Nervous System Tumors Chronic Myeloproliferative Disorders Leukemia +6 more

RECRUITING

FLT PET/CT in Measuring Response in Patients With Previously Untreated Acute Myeloid Leukemia

NCT02392429

Acute Myeloid Leukemia

ACTIVE_NOT_RECRUITING PHASE2

FLT-PET/MRI for Early Response Monitoring to Novel Cancer Therapeutic Agents

NCT02055586

Unspecified Adult Solid Tumor, Protocol Specific

COMPLETED

Serial FLT PET Imaging in Cancer Patients for Monitoring of Response to Therapy

NCT02139150

Histologically-confirmed Malignancies

WITHDRAWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

PRIMARY OBJECTIVES:

I. To determine if concurrent treatment with temsirolimus and bevacizumab demonstrates a dose-dependent decrease in FLT-PET standardized uptake value which correlates with clinical response.

SECONDARY OBJECTIVES:

I. To determine the relationship between FLT-PET and markers of angiogenesis and drug activity in tumor biopsy, along with surrogate peripheral blood markers of target inhibition and drug activity.

OUTLINE:

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Malignant Neoplasm

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Diagnostic (fluorine F-18 fluorothymidine PET)

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.

Group Type EXPERIMENTAL

Fluorothymidine F-18

Intervention Type DRUG

Undergo fluorine F-18 fluorothymidine PET

Laboratory Biomarker Analysis

Intervention Type OTHER

Optional correlative studies

Positron Emission Tomography

Intervention Type PROCEDURE

Undergo fluorine F-18 fluorothymidine PET

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Fluorothymidine F-18

Undergo fluorine F-18 fluorothymidine PET

Intervention Type DRUG

Laboratory Biomarker Analysis

Optional correlative studies

Intervention Type OTHER

Positron Emission Tomography

Undergo fluorine F-18 fluorothymidine PET

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

18F-FLT 3'-Deoxy-3'-(18F) Fluorothymidine 3'-deoxy-3'-[18F]fluorothymidine ALOVUDINE F-18 Fluorothymidine F 18 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

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No