Fluorine F 18 FEQA in Patients With Stage III or Stage IV... | NCT00444223

Studies
Fluorine F 18 FEQA in Patients With Stage III or Stage IV Non-Small Cell Lung Cancer and in Healthy Participants

NCT00444223

Sponsor

Jonsson Comprehensive Cancer Center

Status

Terminated

Last Update Posted

Aug 5, 2020Actual

Enrollment

3Actual

Phase

Not Applicable

Conditions

Lung Cancer

Interventions

fluorine F 18 FEQA + positron emission tomography

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
UCLA-0304039-01

Status Module

Record Verification Date

Feb 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

poor recruitment

Expanded Access Info

Start Date

May 4, 2004Actual

Primary Completion Date

May 15, 2008Actual

Completion Date

May 15, 2008Actual

First Submitted Date

Mar 5, 2007

First Submission Date that Met QC Criteria

Mar 5, 2007

First Posted Date

Mar 7, 2007Estimated

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

Aug 3, 2020

Last Update Posted Date

Aug 5, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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: Fluorine F 18 FEQA may be an effective radioactive drug to use with positron emission tomography (PET) scans.

PURPOSE: This clinical trial is studying the use of fluorine F 18 FEQA in patients with stage III or stage IV non-small cell lung cancer and in healthy participants.

Detailed Description

OBJECTIVES:

Determine the biodistribution of fluorine F 18 FEQA in patients with stage III or IV non-small cell lung cancer (NSCLC) and in healthy participants.
Determine whether fluorine F 18 FEQA can be used as an imaging agent with positron emission tomography in patients with stage III or IV NSCLC.

OUTLINE: This is a pilot study.

Patients and healthy participants receive fluorine F 18 FEQA IV and then undergo whole-body dynamic scans comprising positron emission tomography.

Blood is collected during and after imaging to measure radioactivity.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

3Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
fluorine F 18 FEQA + positron emission tomography	Experimental		Procedure: fluorine F 18 FEQA + positron emission tomography

Interventions

Name	Type	Description	Arm Group Labels	Other Names
fluorine F 18 FEQA + positron emission tomography	Procedure		fluorine F 18 FEQA + positron emission tomography

Measure	Description	Time Frame
Biodistribution of fluorine F 18 FEQA		1 day

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Must meet 1 of the following criteria:
Diagnosis of non-small cell lung cancer by CT scan, bone scan, or biopsy
- Stage III or IV disease
- Clinically assessed with
Healthy participant

Exclusion Criteria:

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Johannes Czernin, MD	Jonsson Comprehensive Cancer Center	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Jonsson Comprehensive Cancer Center at UCLA		Los Angeles	California	90095-1781	United States

Condition Browse Module

MeSH Terms

ID	Term
D008175	Lung Neoplasms
D002289	Carcinoma, Non-Small-Cell Lung

Ancestor Terms

ID	Term
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D009682	Magnetic Resonance Spectroscopy

Ancestor Terms

ID	Term
D013057	Spectrum Analysis
D002623	Chemistry Techniques, Analytical
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided