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OpenTrials
Completed

NCT Number: NCT02424864

4D FDG PET in Esophageal Cancer

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.

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Key information

Conditions

Esophageal Cancer Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Netherlands cancer Institute

Amsterdam, North Holland, 1066CX, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

4d PET-CT

Other

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

Primary outcomes

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

    Time frame: one year

Secondary outcomes

  1. 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

    Time frame: one year

    measurement of the SUV is a composite measurement in each FDG PET scan

Sponsors and collaborators

Lead sponsor

The Netherlands Cancer Institute

Other

Registry information

Official study title

4D PET-CT Imaging in Esophageal Cancer

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Apr 23, 2015
Registry last updated
Sep 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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