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4D FDG PET in Esophageal Cancer

NCT ID: NCT02424864

Last Updated: 2017-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2017-05-19

Brief Summary

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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

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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.

Conditions

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Esophageal Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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4D PET-CT

Other intervention: 4D PET-CT

Group Type OTHER

4d PET-CT

Intervention Type OTHER

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

Interventions

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4d PET-CT

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Netherlands Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Francine Voncken, MD

Role: PRINCIPAL_INVESTIGATOR

NKI-AvL

Locations

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The Netherlands cancer Institute

Amsterdam, North Holland, Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type DERIVED
PMID: 33825916 (View on PubMed)

Other Identifiers

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NL45839.031.13

Identifier Type: REGISTRY

Identifier Source: secondary_id

N14FDG

Identifier Type: -

Identifier Source: org_study_id