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

• Sponsor: Lung Clinic Heckeshorn (Other)
• Overall Status: Completed
• CT.gov ID: NCT02942901
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Actual Duration (Months): 60
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Metastatic Colorectal Cancer	Procedure: PET-CT

Study Design

• Study Type: Observational
• Actual Enrollment: 80 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Clinical Evaluation of PET-CT for Staging of Colorectal Lung Metastases - a Prospective Monocentric Feasibility Study
• Actual Study Start Date: Jan 1, 2015
• Actual Primary Completion Date: Sep 1, 2019
• Actual Study Completion Date: Jan 1, 2020

Outcome Measures

Primary Outcome Measures

1. Overall Survival [5 years]

Secondary Outcome Measures

1. Number and sites of metastases detected by PET-CT [3 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lung Clinic Heckeshorn at HELIOS Hospital Emil von Behring	Berlin		Germany	14165

Sponsors and Collaborators

• Lung Clinic Heckeshorn

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: Lung Clinic Heckeshorn
• ClinicalTrials.gov Identifier: NCT02942901
• Other Study ID Numbers: Oskar Helene 11/2016
• First Posted: Oct 24, 2016
• Last Update Posted: Sep 4, 2020
• Last Verified: Sep 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by Lung Clinic Heckeshorn: PET-CT; pulmonary metstasectomy
• Additional relevant MeSH terms: Colorectal Neoplasms

Study Results

No Results Posted as of Sep 4, 2020