NCT02079181

Brief Summary

This clinical trial studies the safety and drug distribution of the radioactive drug, 2'-deoxy-2'-\[18F\]fluoro-5-methyl-1-beta-D-arabinofuranosyluracil (fluorine F 18 d-FMAU \[18F-FMAU\]), for imaging with positron emission tomography/computed tomography (PET/CT) in patients with advanced cancers. A PET scan is a procedure in which a small amount of radioactive glucose (sugar) is injected into a vein, and a scanner is used to make detailed, computerized pictures of areas inside the body where the glucose is taken up. Because cancer cells often take up more glucose than normal cells, the pictures can be used to find cancer cells in the body. PET/CT using the drug fluorine F 18 d-FMAU, may help find cancer and find out how far the disease has spread.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 31, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 3, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 5, 2014

Completed
9.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 22, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 22, 2023

Completed
Last Updated

May 24, 2024

Status Verified

August 1, 2023

Enrollment Period

9.6 years

First QC Date

March 3, 2014

Last Update Submit

May 22, 2024

Conditions

Malignant Neoplasm

Outcome Measures

Primary Outcomes (3)

  • Radiation dosimetry of fluorine F 18 d-FMAU

    Up to 24 hours after fluorine F 18 d-FMAU PET/CT scan

  • Adverse events after injection of fluorine F 18 d-FMAU to the patients

    Up to 24 hours after fluorine F 18 d-FMAU PET/CT scan

  • Fluorine F 18 d-FMAU uptake change in tumors post-therapy

    Baseline up to 24 hours after fluorine F 18 d-FMAU PET/CT scan

Study Arms (1)

Diagnostic (fluorine F 18 d-FMAU PET/CT scan)

EXPERIMENTAL

Patients receive fluorine F 18 d-FMAU IV followed by PET/CT prior to start of cancer treatment. Patients may undergo 2 additional scans at one week prior to second course of chemotherapy and after completion of cancer treatment depending on cancer type.

Radiation: fluorine F 18 d-FMAUProcedure: positron emission tomographyProcedure: computed tomography

Interventions

fluorine F 18 d-FMAURADIATION

Given IV

Diagnostic (fluorine F 18 d-FMAU PET/CT scan)
positron emission tomographyPROCEDURE

Undergo fluorine F 18 d-FMAU PET/CT scan

Also known as: FDG-PET, PET, PET scan, tomography, emission computed
Diagnostic (fluorine F 18 d-FMAU PET/CT scan)
computed tomographyPROCEDURE

Undergo fluorine F 18 d-FMAU PET/CT scan

Also known as: tomography, computed
Diagnostic (fluorine F 18 d-FMAU PET/CT scan)

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have been diagnosed with a malignancy/tumor/cancer, including but not limited to: brain tumor, breast cancer, lung cancer, esophageal cancer, lymphoma, or sarcoma
  • Have one or more tumors visualized by conventional PET-CT, CT or magnetic resonance imaging (MRI) prior to the PET FMAU study; PET-CT should be within one week prior to 18F-FMAU

You may not qualify if:

  • Have undergone chemotherapy or radiation therapy within the previous one month
  • Women of childbearing potential, unless they have had a negative urine beta human chorionic gonadotropin (betaHCG) within the previous 24 hours of the procedure
  • Patients who have had surgery at the site of the suspected lesion within 1 month

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

USC Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

clevudineMagnetic Resonance Spectroscopy2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazole

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Peter Conti, MD

    University of Southern California

    PRINCIPAL INVESTIGATOR

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

March 3, 2014

First Posted

March 5, 2014

Study Start

January 31, 2014

Primary Completion

August 22, 2023

Study Completion

August 22, 2023

Last Updated

May 24, 2024

Record last verified: 2023-08

Locations

US(1)