Clinical Evaluation of PET-CT for Staging of Colorectal L... | NCT02942901

Studies
Clinical Evaluation of PET-CT for Staging of Colorectal Lung Metastases

NCT02942901

Sponsor

Lung Clinic Heckeshorn

Status

Completed

Last Update Posted

Sep 4, 2020Actual

Enrollment

80Actual

Phase

Not provided

Conditions

Metastatic Colorectal Cancer

Interventions

PET-CT

Countries

Germany

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

Sep 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2015Actual

Primary Completion Date

Sep 1, 2019Actual

Completion Date

Jan 1, 2020Actual

First Submitted Date

Oct 21, 2016

First Submission Date that Met QC Criteria

Oct 21, 2016

First Posted Date

Oct 24, 2016Estimated

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

Sep 3, 2020

Last Update Posted Date

Sep 4, 2020Actual

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

Surgery has been available for the treatment of pulmonary metastases in metastatic colorectal cancer and promising overall survival was observed in retrospective studies with selected patients. This study investigated whether the preoperative FDG- PET/CT scan influences survival in this patient group. Furthermore, we tried to identify other prognostic factors associated with overall survival and progression-free survival.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Name	Type	Description	Arm Group Labels	Other Names
PET-CT	Procedure

Measure	Description	Time Frame
Overall Survival		5 years

Measure	Description	Time Frame
Number and sites of metastases detected by PET-CT		3 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients over 18 years with pulmonary metastases eligible for pulmonary metastasectomy

Exclusion Criteria:

Second primary cancer within the last 2 years (exception basal cell carcinoma of the skin)
Pregnancy,
Drug addiction,
Renal dialysis

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with pulmonary metastases eligible for pulmonary metastasectomy

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Lung Clinic Heckeshorn at HELIOS Hospital Emil von Behring		Berlin		14165	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
14688704	Background	Pastorino U, Veronesi G, Landoni C, Leon M, Picchio M, Solli PG, Leo F, Spaggiari L, Pelosi G, Bellomi M, Fazio F. Fluorodeoxyglucose positron emission tomography improves preoperative staging of resectable lung metastasis. J Thorac Cardiovasc Surg. 2003 Dec;126(6):1906-10. doi: 10.1016/s0022-5223(03)00211-3.

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site