4D FDG PET in Esophageal Cancer

Esophageal Cancer Clinical Trial

Official title:

4D PET-CT Imaging in Esophageal Cancer

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
• 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

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

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