## Protocol Section
### Identification Module
**NCT ID:** 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.

#### Organization Study ID Info
**ID:** EC/2017/0200
#### Organization
**Class:** OTHER
**Full Name:** University Hospital, Ghent
### Status Module
#### Completion Date
**Date:** 2025-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-01-23

**Type:** ACTUAL

**Last Update Submit Date:** 2024-01-20

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2018-01-01

**Type:** ACTUAL

**Status Verified Date:** 2024-01

#### Study First Post Date
**Date:** 2020-04-13
**Type:** ACTUAL
**Study First Submit Date:** 2020-01-20
**Study First Submit QC Date:** 2020-04-08
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University Hospital, Ghent

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

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

### Conditions Module

**Conditions:**

- Breast Cancer Female

- Breast Neoplasms

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 100

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** breast cancer patients

**Intervention Names:**

- Diagnostic Test: PET CT

**Label:** braeast cancer

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- braeast cancer

**Description:** measurement of surgical margins during lumpectomy

**Name:** PET CT

**Type:** DIAGNOSTIC_TEST

### Outcomes Module

#### Primary Outcomes

**Description:** study the feasibility of PET/CT

**Measure:** 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.

**Time Frame:** 2 year

### Eligibility Module

**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.

**Gender Based:** True

**Gender Description:** women with breast cancer

**Maximum Age:** 85 Years

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Ghent

**Contacts:**

***Contact 1:***

- **Email:** menekse.goker@uzgent.be

- **Name:** Menekse Goker

- **Phone:** 0498677037

- **Role:** CONTACT

**Country:** Belgium

**Facility:** University Hospital Ghent

**State:** Oost Vlaanderen

**Status:** RECRUITING

**Zip:** 9000

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000001941

- Term: Breast Diseases

- ID: D000012871

- Term: Skin Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M5220

- Name: Breast Neoplasms

- Relevance: HIGH

- As Found: Breast Cancer

- ID: M5218

- Name: Breast Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15674

- Name: Skin Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001943

- Term: Breast Neoplasms

### Misc Info Module

- Version Holder: 2024-05-24
