NCT01359267

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at P25-P50 for early_phase_1 head-and-neck-cancer

Timeline
Completed

Started Apr 2011

Longer than P75 for early_phase_1 head-and-neck-cancer

Geographic Reach
1 country

1 active site

Status
completed

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

April 19, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 20, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 24, 2011

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2015

Completed
Last Updated

May 8, 2020

Status Verified

May 1, 2020

Enrollment Period

4.4 years

First QC Date

May 20, 2011

Last Update Submit

May 6, 2020

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

  • Persistent Disease within 6 months of CRT

    6 months

Secondary Outcomes (1)

  • Persistent Disease within 2 years of CRT

    2 years

Study Arms (1)

Imaging

EXPERIMENTAL
Drug: 99mTc-EC-DG

Interventions

99mTc-EC-DGDRUG

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.

Imaging

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

technetium 99m ethylenedicysteine deoxyglucose

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Study Officials

  • Everett Vokes, MD

    University of Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2011

First Posted

May 24, 2011

Study Start

April 19, 2011

Primary Completion

September 15, 2015

Study Completion

September 15, 2015

Last Updated

May 8, 2020

Record last verified: 2020-05

Locations

US(1)