Multi-Tracer Positron Emission Tomography in Patients With Solid Tumors

NCT01243333 | Terminated Results DMC

• 2 other identifiers: HCI43948NCI-2011-03665
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Neoplasm

Outcome Measures

Primary Outcomes (3)

• FDG Therapeutic Response

  The patients underwent baseline and repeat PET/CT imaging (after one to two cycles of treatment) with \[F-18\]fluorodeoxyglucose (FDG) and \[F-18\]fluorothymidine (FLT). The percent change in the SUVmax for FDG was calculated and used to determine the response. Partial response (PR) was defined as 35% or greater reduction in SUVmax, Progressive Disease (PD) was defined as 35% or greater increase in SUVmax, and Stable Disease (SD) was defined as all other changes in SUVmax.

  1-2 cycles of treatment - approximately one month

• FLT Therapeutic Response

  The patients underwent baseline and repeat PET/CT imaging (after one to two cycles of treatment) with \[F-18\]fluorodeoxyglucose (FDG) and \[F-18\]fluorothymidine (FLT). The percent change in the SUVmax for FLT was calculated and used to determine the response. Partial response (PR) was defined as 35% or greater reduction in SUVmax, Progressive Disease (PD) was defined as 35% or greater increase in SUVmax, and Stable Disease (SD) was defined as all other changes in SUVmax.

  1-2 cycles of treatment - approximately one month

• Standard Therapeutic Response

  The patients underwent baseline and repeat PET/CT imaging (after one to two cycles of treatment) with \[F-18\]fluorodeoxyglucose (FDG) and \[F-18\]fluorothymidine (FLT). Percent change in lesion measurements according to standard response criteria for the patient's tumor type were obtained. For brain tumors, Response Assessment in Neuro-Oncology (RANO) criteria were used. Partial Response (PR) was defined as 50% or greater reduction in lesion measurements, Progressive Disease (PD) was 25% or greater increase in measurements, and Stable Disease (SD) was neither PD or PR. Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria were used for solid tumors, with PR defined as 30% or greater reduction in measurements, PD was 20% or greater increase in measurements, and SD was all other changes.

  1-2 cycles of treatment - approximately one month

Study Arms (1)

Diagnostic (multi-tracer PET scans)

EXPERIMENTAL

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.

Radiation: [F-18]fluorodeoxyglucose; Radiation: [F-18]fluorothymidine; Procedure: Positron Emission Tomography; Radiation: Water O-15

Interventions

[F-18]fluorodeoxyglucose RADIATION

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

Also known as: 18FDG, FDG, fludeoxyglucose F 18, Fludeoxyglucose F-18, Fludeoxyglucose F18, Fluorine-18 2-Fluoro-2-deoxy-D-Glucose, Fluorodeoxyglucose F18

Diagnostic (multi-tracer PET scans)

[F-18]fluorothymidine RADIATION

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

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

Diagnostic (multi-tracer PET scans)

Positron Emission Tomography PROCEDURE

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

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging

Diagnostic (multi-tracer PET scans)

Water O-15 RADIATION

Undergo PET scans with water O-15 tracers

Also known as: [15O] Water, [15O]-H2O

Diagnostic (multi-tracer PET scans)

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Fluorodeoxyglucose F18; alovudine; Magnetic Resonance Spectroscopy; Water

Intervention Hierarchy (Ancestors)

Deoxyglucose; Deoxy Sugars; Carbohydrates; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Results Point of Contact

• Title: Josiah Hawks
• Organization: Huntsman Cancer Institute Research Compliance Officer

Josiah.Hawks@hci.utah.edu

8015850601

Study Officials

• Jeffrey Yap, PhD

  Huntsman Cancer Institute/ University of Utah

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2010
• First Posted: November 18, 2010
• Study Start: February 2, 2011
• Primary Completion: December 12, 2015
• Study Completion: April 8, 2016
• Last Updated: April 17, 2024
• Results First Posted: August 21, 2019

Record last verified: 2024-04

Locations

US (1)