NCT02424864

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 30, 2015

Completed
24 days until next milestone

First Posted

Study publicly available on registry

April 23, 2015

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 19, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 19, 2017

Completed
Last Updated

September 28, 2017

Status Verified

January 1, 2017

Enrollment Period

2.8 years

First QC Date

March 30, 2015

Last Update Submit

September 26, 2017

Conditions

Esophageal Cancer

Keywords

4D PET-CT

Outcome Measures

Primary Outcomes (1)

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

    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

    one year

Study Arms (1)

4D PET-CT

OTHER

Other intervention: 4D PET-CT

Other: 4d PET-CT

Interventions

4d PET-CTOTHER

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

4D PET-CT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • \<18 years
  • Possibility of pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Netherlands cancer Institute

Amsterdam, North Holland, 1066CX, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 33825916DERIVED

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Study Officials

  • Francine Voncken, MD

    NKI-AvL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2015

First Posted

April 23, 2015

Study Start

August 1, 2014

Primary Completion

May 19, 2017

Study Completion

May 19, 2017

Last Updated

September 28, 2017

Record last verified: 2017-01

Locations

NL(1)