Wayne State University - Human Investigation Committee
Brief Title
3'-Deoxy-3'-[18F] Fluorothymidine PET Imaging in Patients With Cancer
Official Title
Use of [F-18] FLT for Imaging With Positron Emission Tomography (PET)
Acronym
Not provided
Organization
Barbara Ann Karmanos Cancer InstituteOTHER
Status Module
Record Verification Date
Jul 2025
Overall Recruitment Status or Expanded Access Status
Recruiting
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Sep 2009Actual
Primary Completion Date
May 2027Estimated
Completion Date
May 2028Estimated
First Submitted Date
Jul 7, 2009
First Submission Date that Met QC Criteria
Jul 7, 2009
First Posted Date
Jul 8, 2009Estimated
Results Waived
Not provided
Results First Submitted Date
Not provided
Results First Submitted that Met QC Criteria
Not provided
Results First Posted Date
Not provided
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jul 2, 2025
Last Update Posted Date
Jul 8, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Anthony F. Shields, MD PhD, Principal Investigator, Barbara Ann Karmanos Cancer InstitutePrincipal Investigator
Lead Sponsor
Barbara Ann Karmanos Cancer InstituteOTHER
Collaborators
Name
Class
National Cancer Institute (NCI)
NIH
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
RATIONALE: Diagnostic procedures, such as 3'-deoxy-3'-[18F] fluorothymidine (FLT) PET imaging, may help find and diagnose cancer. It may also help doctors predict a patient's response to treatment and help plan the best treatment.
PURPOSE: This phase I trial is studying FLT PET imaging in patients with cancer.
Detailed Description
OBJECTIVES:
Primary
Evaluate the use of 3'-deoxy-3'-[18F] fluorothymidine (FLT) positron emission tomography (PET) imaging to measure tumor proliferation and the DNA synthetic pathway (thymidine kinase levels) in patients with cancer.
Secondary
Determine the efficacy of FLT PET imaging in detecting lesions and estimating response to treatment.
OUTLINE: Patients undergo up to four 3'-deoxy-3'-[18F] fluorothymidine positron emission tomography imaging procedures.
Conditions Module
Conditions
Brain and Central Nervous System Tumors
Chronic Myeloproliferative Disorders
Leukemia
Lymphoma
Lymphoproliferative Disorder
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Neoplasms
Unspecified Adult Solid Tumor, Protocol Specific
Keywords
unspecified adult solid tumor, protocol specific
accelerated phase chronic myelogenous leukemia
acute undifferentiated leukemia
adult acute lymphoblastic leukemia in remission
adult acute myeloid leukemia in remission
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with t(15;17)(q22;q12)
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia with t(8;21)(q22;q22)
The PET scan data collection is started immediately and is continued for 2 hours. This procedure will measure tumor growth within the body.
Device: 3'-deoxy-3'-[18F]fluorothymidine
Interventions
Name
Type
Description
Arm Group Labels
Other Names
3'-deoxy-3'-[18F]fluorothymidine
Device
The tracer compound [F-18] FLT will be injected into the patient's veins in a small volume of normal saline solution. The PET scan data collection is started immediately and is continued for 2 hours. This procedure will measure tumor growth within the body. Blood may be withdrawn (through the catheters) up to a total volume of 30 milliliters (or 2 tablespoons) for each scan. A urine sample may be collected at the end of the imaging of the tracer compound to analyze its breakdown products.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Measurement of the uptake and retention of 3'-deoxy-3'-[18F] fluorothymidine (FLT) in tumors and normal organs
at time of PET or CT PET Scan
Changes in thymidine kinase, thymidylate synthase, and standardized uptake values
before and after therapy
Secondary Outcomes
Measure
Description
Time Frame
FLT PET response rate
up to 2 hours during PET scan
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
DISEASE CHARACTERISTICS:
Meets one of the following criteria:
Histologically confirmed solid tumor or hematologic malignancy
Awaiting biopsy or surgery for cancer evaluation of a mass detected on exam or standard imaging
PATIENT CHARACTERISTICS:
Able to lie still in the PET scanner
Girth and weight must be suitable to enter the gantry
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Not specified
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
120 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Anthony F. Shields, MD, PhD
Barbara Ann Karmanos Cancer Institute
Principal Investigator
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Barbara Ann Karmanos Cancer Institute
Recruiting
Detroit
Michigan
48201-1379
United States
References Module
Citations
Not provided
See Also Links
Label
URL
Clinical trial summary from the National Cancer Institute's PDQ® database