Multi-Tracer Positron Emission Tomography in Patients With Solid Tumors

NCT ID: NCT01243333

Last Updated: 2024-04-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-02
• Study Completion Date: 2016-04-08

Brief Summary

This clinical trial studies multi-tracer positron emission tomography in patients with solid tumors. Diagnostic procedures, such as multi-tracer positron emission tomography, may help measure a patient's response to treatment.

Detailed Description

PRIMARY OBJECTIVES:

I. Provide a reliable and validated cadre of positron emission tomography (PET) imaging derived biomarkers that yield a better understanding of: 1) early clinical benefit from various therapeutic agents in investigational and recently approved therapies; 2) efficacy during novel therapeutics in investigational therapeutics and recently approved therapeutics at Huntsman Cancer Institute (HCI); and 3) possible predict prognosis or other long-term outcomes.

II. Reveal a more detailed understanding of: (1) the in vivo biologic mechanisms of various therapeutic drugs in investigational therapies and recently approved therapies at HCI (2) information on why particular functional imaging profiles are seen in treated patients.

III. Reveal a more detailed understanding of how the combination of molecular imaging derived biomarkers will be potentially useful to physicians for decision making and for explanation of efficacy or outcomes for patients with cancer.

IV. Implement and evaluate a new imaging technology for multi-tracer PET imaging of these tracers.

OUTLINE:

Patients undergo PET scans with fludeoxyglucose (FDG) F 18 (18FDG), fluorine F 18 fluorothymidine (FLT), and water (H2O) O-15 (15O) tracers at baseline and within 7 days of completion of 1 or 2 (if the course is less than 3 weeks) therapeutic agent courses.

Conditions

Malignant Neoplasm

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Diagnostic (multi-tracer PET scans)

Patients undergo Positron Emission Tomography (PET) scans with \[F-18\]fluorodeoxyglucose and \[F-18\]fluorothymidine at baseline and within 7 days of completion of 1 or 2 (if the course is less than 3 weeks) therapeutic agent courses.

Group Type: EXPERIMENTAL

[F-18]fluorodeoxyglucose

Intervention Type: RADIATION

Undergo PET scans with \[F-18\]fluorodeoxyglucose

[F-18]fluorothymidine

Intervention Type: RADIATION

Undergo PET scans with fluorine \[F-18\]fluorothymidine

Positron Emission Tomography

Intervention Type: PROCEDURE

Undergo PET scans with 3 radiotracers (fludeoxyglucose F 18, fluorine F 18 fluorothymidine, and water O-15)

Water O-15

Intervention Type: RADIATION

Undergo PET scans with water O-15 tracers

Interventions

[F-18]fluorodeoxyglucose

Undergo PET scans with \[F-18\]fluorodeoxyglucose

Intervention Type: RADIATION

[F-18]fluorothymidine

Undergo PET scans with fluorine \[F-18\]fluorothymidine

Intervention Type: RADIATION

Positron Emission Tomography

Undergo PET scans with 3 radiotracers (fludeoxyglucose F 18, fluorine F 18 fluorothymidine, and water O-15)

Intervention Type: PROCEDURE

Water O-15

Undergo PET scans with water O-15 tracers

Intervention Type: RADIATION

Other Intervention Names

18FDG; FDG; fludeoxyglucose F 18; Fludeoxyglucose F-18; Fludeoxyglucose F18; Fluorine-18 2-Fluoro-2-deoxy-D-Glucose; Fluorodeoxyglucose F18; 18F-FLT; 3'-Deoxy-3'-(18F) Fluorothymidine; 3'-deoxy-3'-[18F]fluorothymidine; ALOVUDINE F-18; fluorothymidine F 18; FLT; Fluorothymidine F-18; Medical Imaging, Positron Emission Tomography; PET; PET Scan; Positron Emission Tomography Scan; Positron-Emission Tomography; proton magnetic resonance spectroscopic imaging; [15O] Water; [15O]-H2O

Eligibility Criteria

Inclusion Criteria

• Patients must document their willingness to be followed for a period of time; for the purposes of imaging data analysis this will ideally be for at least 12 months after completing the investigational or recently approved therapy, however this may not always be possible; by signing informed consent, the patients are documenting their agreement to have clinical and radiographic endpoints and the results of histopathologic tissue analysis and other laboratory information entered into a research database
• All patients must sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelines
• Female patients who are not postmenopausal or surgically sterile will undergo a serum pregnancy test prior to baseline and the subsequent set of multi-tracer PET scans; the serum pregnancy test must be performed within 48 hours prior to research PET imaging; a negative test will be necessary for such patients to undergo research PET imaging
• Serum glutamic oxaloacetic transaminase (SGOT) less than 4.0 times below or above the upper or lower limit range
• Serum glutamate pyruvate transaminase (SGPT) less than 4.0 times below or above the upper or lower limit range
• Alkaline phosphatase (ALK phos) less than 4.0 times below or above the upper or lower limit range
• Lactate dehydrogenase (LDH) less than 4.0 times below or above the upper or lower limit range
• Total bilirubin less than 4.0 times below or above the upper or lower limit range
• Serum electrolytes less than 4.0 times below or above the upper or lower limit range
• Complete blood count (CBC) with platelets less than 4.0 times below or above the upper or lower limit range
• Prothrombin time less than 2.5 times below or above the upper or lower limit range; for those patients receiving Coumadin or another anticoagulant the upper limit for prothrombin time must not exceed 6 times the upper limit of the normal range
• Partial thromboplastin time less than 2.5 times below or above the upper or lower limit range; for those patients receiving Coumadin or another anticoagulant the upper limit for partial thromboplastin time must not exceed 6 times the upper limit of the normal range
• Blood urea nitrogen (BUN) less than 4.0 times below or above the upper or lower limit range
• Creatinine less than 4.0 times below or above the upper or lower limit range
• Urinalysis less than 4.0 times below or above the upper or lower limit range; urinalysis abnormalities will not preclude the patient from being enrolled and studied

Exclusion Criteria

• Patients with known allergic or hypersensitivity reactions to previously administered radiopharmaceuticals; patients with significant drug or other allergies or autoimmune diseases may be enrolled at the Investigator's discretion
• Patients who are pregnant or lactating or who suspect they might be pregnant; serum pregnancy tests will be obtained prior to the baseline and subsequent multi-tracer PET scans in female patients that are not postmenopausal or surgically sterile
• Adult patients who require monitored anesthesia for PET scanning
• Patients known to be human immunodeficiency virus (HIV) positive

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Utah

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeffrey Yap, PhD

Role: PRINCIPAL_INVESTIGATOR

Huntsman Cancer Institute/ University of Utah

Locations

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

NCI-2011-03665

Identifier Type: REGISTRY

Identifier Source: secondary_id

HCI43948

Identifier Type: -

Identifier Source: org_study_id