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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02424864
Other study ID # N14FDG
Secondary ID NL45839.031.13
Status Completed
Phase N/A
First received March 30, 2015
Last updated September 26, 2017
Start date August 2014
Est. completion date May 19, 2017

Study information

Verified date January 2017
Source The Netherlands Cancer Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 54
Est. completion date May 19, 2017
Est. primary completion date May 19, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
4d PET-CT
Patients will be imaged with 4D-CT images in addition to the normal protocol of FDG-CT image acquisition

Locations

Country Name City State
Netherlands The Netherlands cancer Institute Amsterdam Noord-Holland

Sponsors (1)

Lead Sponsor Collaborator
The Netherlands Cancer Institute

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary The estimation of tumor size of the primary esophageal tumor on 4Dvs 3D FDG PET one year
Secondary 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 one year
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