NCT01051479

Brief Summary

The purpose of this study is to evaluate the investigators ability to obtain reliable and meaningful 11C-Choline PET-CT images of esophageal cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Mar 2010

Typical duration for phase_1

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

First Submitted

Initial submission to the registry

January 15, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 18, 2010

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2010

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

July 2, 2018

Status Verified

June 1, 2018

Enrollment Period

3.4 years

First QC Date

January 15, 2010

Last Update Submit

June 29, 2018

Conditions

Esophageal Cancer

Keywords

PET Positron emission tomographyCT X-ray computed tomographyPatients with Locally Advanced Esophageal Cancer

Outcome Measures

Primary Outcomes (1)

  • To evaluate our ability to obtain reliable and meaningful 11C-Choline PET-CT images of esophageal cancer (pre- and post- chemotherapy).

    2 years

Secondary Outcomes (1)

  • Perform semi-quantitative analysis of tracer uptake using standard uptake values (SUV) and qualitative analysis using pure visual analysis.

    2 years

Study Arms (1)

C11-Choline

EXPERIMENTAL
Drug: C11-Choline

Interventions

C11-CholineDRUG

15 mCi 11C-choline will be administered intravenously as a bolus. The whole body emission scans will be acquired immediately following the tracer injection.

C11-Choline

Eligibility Criteria

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

You may qualify if:

  • Newly diagnosed or recurrent patients with locally advanced esophageal cancer with either squamous or adenocarcinoma histology.
  • Ability to tolerate PET imaging
  • Prior malignancy is allowed, but the expectation of survival must be that beyond that expected for patients with locally advanced esophageal cancer.

You may not qualify if:

  • Pregnant or lactating females are not eligible for this pilot study.
  • Patients having received chemotherapy in the 3 months prior to registration for any reason
  • Patients with metastatic disease requiring chemoradiation for palliation are not allowed.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Study Design

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

Study Record Dates

First Submitted

January 15, 2010

First Posted

January 18, 2010

Study Start

March 1, 2010

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

July 2, 2018

Record last verified: 2018-06

Locations

US(1)