Intra-operative PET-CT: a Novel Approach to Determine Excision Margins in Lumpectomy Breast Cancer.

• Sponsor: University Hospital, Ghent (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04343079
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 72
• Patients Per Site Per Month: 1.4

Study Details

Study Description

Brief Summary

Examination of the feasibility of intra-operative pet CT to detect surgical margins in breast conservative surgery to prevent re-excision.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Female; Breast Neoplasms	Diagnostic Test: PET CT	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Intra-operative PET-CT: a Novel Approach to Determine Excision Margins in Lumpectomy Breast Cancer.
• Actual Study Start Date: Jan 1, 2018
• Anticipated Primary Completion Date: Dec 15, 2022
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: braeast cancer breast cancer patients	Diagnostic Test: PET CT; measurement of surgical margins during lumpectomy

Outcome Measures

Primary Outcome Measures

1. investigate the ability of (micro)PET/CT to evaluate the excision margins and determine negativity of these margins, as compared to the gold standard of sectional histopathological evaluation. [2 year]

   study the feasibility of PET/CT

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• • female and 18 years of age or older

• diagnosed with an early-stage (T1 or T2, and N0 or N1; according to the TNM-classification) invasive breast cancer

• eligible for breast conserving surgery

Exclusion Criteria:

• • Pregnancy or lactation

• Diabetes

• Multifocal tumor disease

• Diagnosis of inflammatory breast cancer

• Appointment at the nuclear medicine department for 18F-FDG administration would result in a unacceptable delay of surgery

• Subject has had exposure to ionizing radiation of more than 1 mSv in other research studies within the last 12 months

• Subject has recently (<60 days) or is simultaneously participating in another clinical trial.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Ghent	Ghent	Oost Vlaanderen	Belgium	9000

Sponsors and Collaborators

• University Hospital, Ghent

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Ghent
• ClinicalTrials.gov Identifier: NCT04343079
• Other Study ID Numbers: EC/2017/0200
• First Posted: Apr 13, 2020
• Last Update Posted: Apr 13, 2020
• Last Verified: Jan 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Breast Neoplasms

Study Results

No Results Posted as of Apr 13, 2020