Feasibility of Imaging in the Treatment of Patients With... | NCT01359267

Studies
Feasibility of Imaging in the Treatment of Patients With Advanced Head and Neck Cancer

NCT01359267

Sponsor

University of Chicago

Status

Completed

Last Update Posted

May 8, 2020Actual

Enrollment

12Actual

Phase

Early Phase 1

Conditions

Head and Neck Cancer

Interventions

99mTc-EC-DG

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

Status Module

Record Verification Date

May 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 19, 2011Actual

Primary Completion Date

Sep 15, 2015Actual

Completion Date

Sep 15, 2015Actual

First Submitted Date

May 20, 2011

First Submission Date that Met QC Criteria

May 23, 2011

First Posted Date

May 24, 2011Estimated

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

May 6, 2020

Last Update Posted Date

May 8, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

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

The purpose of this study is to obtain preliminary information on the potential of 99m Tc-EC-DG SPECT imaging to distinguish cancer from non cancer.

Detailed Description

Not provided

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

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Imaging	Experimental		Drug: 99mTc-EC-DG

Interventions

Name	Type	Description	Arm Group Labels	Other Names
99mTc-EC-DG	Drug	99mTc-EC-DG will be used before the SPECT/CT scans throughout the study to determine the its effectiveness. 20 mCi of 99mtc-EC-DG will be administered through a vein through a catheter. This will be done before the SPECT/CT scan at 4 weeks and 10 weeks.

Measure	Description	Time Frame
Persistent Disease within 6 months of CRT		6 months

Measure	Description	Time Frame
Persistent Disease within 2 years of CRT		2 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Treatment naive patients with histologically proven cancer of the head and neck
T4 primary tumor (all sites), N2 or N3 locoregional disease (all sites)
At least one measurable site of disease
At least 18 years of age
Karnofsky performance status > or = 70% or ECOG <2
Able to tolerate SPECT/CT imaging
Adequate bone marrow function
Adequate liver function
Adequate renal function
Written consent from patients
Female patients of childbearing potential must have a negative pregnancy test within 0-7 days prior to the first SPECT study

Exclusion Criteria:

Diabetics with insulin dependence or blood sugar levels >200 mg/dL prior to imaging
Patient weight above the SPECT/CT table weight limit
Pregnant and/or lactating female
Unequivocal demonstration of metastatic disease
Patients unwilling to or unable to comply with protocol

Accepts Healthy Volunteers

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
Everett Vokes, MD	University of Chicago	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Chicago		Chicago	Illinois	60637	United States

ID	Term
D006258	Head and Neck Neoplasms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms

Intervention Browse Module

MeSH Terms

ID	Term
C522236	technetium 99m ethylenedicysteine deoxyglucose

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided