18F-FDG PET/CT and Molecular Tumor Characterisation for S... | NCT01636674

Studies
18F-FDG PET/CT and Molecular Tumor Characterisation for Staging and Follow-up of Colon Cancer

NCT01636674

Sponsor

Naestved Hospital

Status

Unknown status

Last Update Posted

Jul 10, 2012Estimated

Enrollment

66Actual

Phase

Not Applicable

Conditions

Colon Cancer

Interventions

18F-fluordeoxyglucose positron emission tomography/ computed tomography

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2009

Primary Completion Date

Mar 2013Estimated

Completion Date

Mar 2013Estimated

First Submitted Date

Jul 6, 2012

First Submission Date that Met QC Criteria

Jul 9, 2012

First Posted Date

Jul 10, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 9, 2012

Last Update Posted Date

Jul 10, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Bodil Elisabeth Engelmann, MD, research fellow, Naestved HospitalPrincipal Investigator

Lead Sponsor

Naestved HospitalOTHER

Collaborators

Name	Class
University of Copenhagen	OTHER
Rigshospitalet, Denmark	OTHER
Region Zealand	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

66Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
18F-fluordeoxyglucose positron emission tomography/ computed tomography	Other	18F-fluordeoxyglucose positron emission tomography/ computed tomography for preoperative staging and post-operative follow-up

Measure	Description	Time Frame
time to recurrence

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bodil E Engelmann, MD	Naestved Hospital	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003110	Colonic Neoplasms
D009369	Neoplasms

Ancestor Terms

ID	Term
D015179	Colorectal Neoplasms
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided