## Protocol Section
### Identification Module
**NCT ID:** NCT01051479

**Brief Title:** A Pilot C11-Choline PET-CT Imaging Study in Patients With Locally Advanced Esophageal Cancer

**Official Title:** A Pilot C11-Choline PET-CT Imaging Study in Patients With Locally Advanced Esophageal Cancer

#### Organization Study ID Info
**ID:** IRB00012072
#### Organization
**Class:** OTHER
**Full Name:** Wake Forest University Health Sciences
#### Secondary ID Infos
**Domain:** Wake Forest University Health Sciences
**ID:** CCCWFU 60109
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2013-08

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2018-07-02

**Type:** ACTUAL

**Last Update Submit Date:** 2018-06-29

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2013-08

**Type:** ACTUAL

#### Start Date
**Date:** 2010-03

**Status Verified Date:** 2018-06

#### Study First Post Date
**Date:** 2010-01-18
**Type:** ESTIMATED
**Study First Submit Date:** 2010-01-15
**Study First Submit QC Date:** 2010-01-15
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Wake Forest University Health Sciences

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Oversight Has DMC:** True

### Description Module

**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.

### Conditions Module

**Conditions:**

- Esophageal Cancer

**Keywords:**

- PET Positron emission tomography

- CT X-ray computed tomography

- Patients with Locally Advanced Esophageal Cancer

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** DIAGNOSTIC

#### Enrollment Info

**Count:** 22

**Type:** ACTUAL

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Drug: C11-Choline

**Label:** C11-Choline

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- C11-Choline

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

**Name:** C11-Choline

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

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

**Time Frame:** 2 years

#### Secondary Outcomes

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

**Time Frame:** 2 years

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Winston-Salem

**Country:** United States

**Facility:** Wake Forest University Health Sciences

**State:** North Carolina

**Zip:** 27157

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000005770

- Term: Gastrointestinal Neoplasms

- ID: D000004067

- Term: Digestive System Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000006258

- Term: Head and Neck Neoplasms

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000004935

- Term: Esophageal Diseases

- ID: D000005767

- Term: Gastrointestinal Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M8088

- Name: Esophageal Neoplasms

- Relevance: HIGH

- As Found: Esophageal Cancer

- ID: M8886

- Name: Gastrointestinal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7256

- Name: Digestive System Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M9348

- Name: Head and Neck Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8085

- Name: Esophageal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T2141

- Name: Esophageal Cancer

- Relevance: HIGH

- As Found: Esophageal Cancer

### Condition Browse Module - Meshes

- ID: D000004938

- Term: Esophageal Neoplasms

### Intervention Browse Module - Ancestors

- ID: D000008082

- Term: Lipotropic Agents

- ID: D000000960

- Term: Hypolipidemic Agents

- ID: D000000963

- Term: Antimetabolites

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000005765

- Term: Gastrointestinal Agents

- ID: D000057847

- Term: Lipid Regulating Agents

- ID: D000018697

- Term: Nootropic Agents

### Intervention Browse Module - Browse Branches

- Abbrev: NootAg

- Name: Nootropic Agents

- Abbrev: Gast

- Name: Gastrointestinal Agents

- Abbrev: Lipd

- Name: Lipid Regulating Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Vi

- Name: Vitamins

### Intervention Browse Module - Browse Leaves

- ID: M6034

- Name: Choline

- Relevance: HIGH

- As Found: Margin

- ID: M4278

- Name: Hypolipidemic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4281

- Name: Antimetabolites

- Relevance: LOW

- As Found: Unknown

- ID: M8881

- Name: Gastrointestinal Agents

- Relevance: LOW

- As Found: Unknown

- ID: M28883

- Name: Lipid Regulating Agents

- Relevance: LOW

- As Found: Unknown

- ID: M20774

- Name: Nootropic Agents

- Relevance: LOW

- As Found: Unknown

- ID: T443

- Name: Choline

- Relevance: HIGH

- As Found: Margin

### Intervention Browse Module - Meshes

- ID: D000002794

- Term: Choline

### Misc Info Module

- Version Holder: 2024-05-24
