NCT01636674

Brief Summary

The investigators are investigating the usefulness of 18F-Fluordeoxyglucose Positron Emission Tomography/ Computed Tomography (18F-FDG PET/CT) for staging and follow-up of colon cancer. Furthermore, the investigators combine 18F-FDG PET findings with clinical and histopathological features, circulating tumor cell (CTC) analyses, tumor gene expression and measurements of circulating cancer biomarkers sUPAR, TIMP-1 and CEA in order to predict tumor recurrence. The investigators hypothesis: The combination of functional imaging by 18F-FDG PET/CT and pre-existing and evolving molecular biomarkers will optimize tumor characterization, staging of disease and early detection of recurrence.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2009

Longer than P75 for not_applicable

Status
unknown

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

July 1, 2009

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

July 6, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 10, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

July 10, 2012

Status Verified

July 1, 2012

Enrollment Period

3.7 years

First QC Date

July 6, 2012

Last Update Submit

July 9, 2012

Conditions

Colon Cancer

Keywords

positron emission tomographycomputed tomographyfluordeoxyglucosecolon cancercancerstagingimaging

Outcome Measures

Primary Outcomes (1)

  • time to recurrence

Interventions

18F-fluordeoxyglucose positron emission tomography/ computed tomographyOTHER

18F-fluordeoxyglucose positron emission tomography/ computed tomography for preoperative staging and post-operative follow-up

Eligibility Criteria

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

You may qualify if:

  • clinical or histological diagnosis of malignant clonic neoplasm (distance of more than 15 cm from anal ring)
  • years of age or older
  • written informed consent

You may not qualify if:

  • diabetes
  • known malignant disease other than colon cancer
  • known metastatic disease
  • impairment of renal function
  • allergy to CT contrast agents
  • body weight of more than 150 kg
  • claustrophobia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Colonic NeoplasmsNeoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Bodil E Engelmann, MD

    Naestved Hospital

    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
PRINCIPAL INVESTIGATOR
PI Title
MD, research fellow

Study Record Dates

First Submitted

July 6, 2012

First Posted

July 10, 2012

Study Start

July 1, 2009

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

July 10, 2012

Record last verified: 2012-07