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4D FDG PET in Esophageal Cancer

Primary Purpose

Esophageal Cancer

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
4d PET-CT
Sponsored by
The Netherlands Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Esophageal Cancer focused on measuring 4D PET-CT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with pathology proven esophageal cancer or tumor highly suspicious for esophageal cancer
  • > 18 years
  • Written informed consent

Exclusion Criteria:

  • <18 years
  • Possibility of pregnancy

Sites / Locations

  • The Netherlands cancer Institute

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

4D PET-CT

Arm Description

Other intervention: 4D PET-CT

Outcomes

Primary Outcome Measures

The estimation of tumor size of the primary esophageal tumor on 4Dvs 3D FDG PET

Secondary Outcome Measures

Measurement of SUV max, SUV mean, and SUV peak in 4D versus 3D images of esophageal cancer and lymph nodes and number of suspected involved lymph nodes
measurement of the SUV is a composite measurement in each FDG PET scan

Full Information

First Posted
March 30, 2015
Last Updated
September 26, 2017
Sponsor
The Netherlands Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02424864
Brief Title
4D FDG PET in Esophageal Cancer
Official Title
4D PET-CT Imaging in Esophageal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
May 19, 2017 (Actual)
Study Completion Date
May 19, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Netherlands Cancer Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
FDG PET-CT image acquisition in the abdominal and thoracic region is influenced by organ motion. Respiratory movement blurs the metabolic signal of the esophageal tumor and lymph nodes. The investigators hypothesize that the metabolic signal obtained with motion compensation results in higher SUV-max values and clearer demarcation of the esophageal tumor and lymph nodes.
Detailed Description
Patients will receive a normal 3D FDG PET-CT scan. By participating in this trial, one extra 4D CT scan will be made. For both the PET and the 4D CT acquisition, the patient gets an abdominal belt around the waist to register breathing motion. No extra FDG PET scan is required for this study. The 4D CT scan is the only intervention which increases the radiation dose exposure compared to the standard PET-CT scan. However, in comparison to the expected radiation dose delivered, if a patient will be treated with curative chemoradiotherapy, this increase in radiation dose is negligible and secondary risks due to this intervention are therefore not increased. For patients who are not eligible for curative treatment the extra dose is also not relevant, given the life expectancy of this group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer
Keywords
4D PET-CT

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
4D PET-CT
Arm Type
Other
Arm Description
Other intervention: 4D PET-CT
Intervention Type
Other
Intervention Name(s)
4d PET-CT
Intervention Description
Patients will be imaged with 4D-CT images in addition to the normal protocol of FDG-CT image acquisition
Primary Outcome Measure Information:
Title
The estimation of tumor size of the primary esophageal tumor on 4Dvs 3D FDG PET
Time Frame
one year
Secondary Outcome Measure Information:
Title
Measurement of SUV max, SUV mean, and SUV peak in 4D versus 3D images of esophageal cancer and lymph nodes and number of suspected involved lymph nodes
Description
measurement of the SUV is a composite measurement in each FDG PET scan
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with pathology proven esophageal cancer or tumor highly suspicious for esophageal cancer > 18 years Written informed consent Exclusion Criteria: <18 years Possibility of pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francine Voncken, MD
Organizational Affiliation
NKI-AvL
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Netherlands cancer Institute
City
Amsterdam
State/Province
Noord-Holland
ZIP/Postal Code
1066CX
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
33825916
Citation
Voncken FEM, Vegt E, van Sandick JW, van Dieren JM, Grootscholten C, Bartels-Rutten A, Takken SL, Sonke JJ, van de Kamer JB, Aleman BMP. Motion-compensated FDG PET/CT for oesophageal cancer. Strahlenther Onkol. 2021 Sep;197(9):791-801. doi: 10.1007/s00066-021-01761-w. Epub 2021 Apr 7.
Results Reference
derived

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4D FDG PET in Esophageal Cancer

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