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

Primary Purpose

Breast Cancer Female, Breast Neoplasms

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
PET CT
Sponsored by
University Hospital, Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer Female

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • University Hospital GhentRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

braeast cancer

Arm Description

breast cancer patients

Outcomes

Primary Outcome Measures

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.
study the feasibility of PET/CT

Secondary Outcome Measures

Full Information

First Posted
January 20, 2020
Last Updated
January 3, 2023
Sponsor
University Hospital, Ghent
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1. Study Identification

Unique Protocol Identification Number
NCT04343079
Brief Title
Intra-operative PET-CT: a Novel Approach to Determine Excision Margins in Lumpectomy Breast Cancer.
Official Title
Intra-operative PET-CT: a Novel Approach to Determine Excision Margins in Lumpectomy Breast Cancer.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Female, Breast Neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
braeast cancer
Arm Type
Experimental
Arm Description
breast cancer patients
Intervention Type
Diagnostic Test
Intervention Name(s)
PET CT
Intervention Description
measurement of surgical margins during lumpectomy
Primary Outcome Measure Information:
Title
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.
Description
study the feasibility of PET/CT
Time Frame
2 year

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
women with breast cancer
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
University Hospital Ghent
City
Ghent
State/Province
Oost Vlaanderen
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Menekse Goker
Phone
0498677037
Email
menekse.goker@uzgent.be

12. IPD Sharing Statement

Learn more about this trial

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

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