Feasibility Study of Using Molecular Fluorescence Guided Surgery in Endometriosis

NCT ID: NCT02975219

Last Updated: 2017-06-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-01

Study Completion Date

2019-01-31

Brief Summary

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Incomplete resection of endometriosis lesions often results in recurrence of symptoms and the need for repeated surgery, with considerable associated morbidity. The aim of this pilot project is to determine the feasibility of fluorescence imaging to improve the treatment of endometriosis in the future.

Detailed Description

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Conditions

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Endometriosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment group

4.5mg Bevacizumab-800CW intravenously

Group Type EXPERIMENTAL

Bevacizumab-800CW

Intervention Type DRUG

4.5mg Bevacizumab-800CW will be administered intravenously three days prior to surgery

Interventions

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Bevacizumab-800CW

4.5mg Bevacizumab-800CW will be administered intravenously three days prior to surgery

Intervention Type DRUG

Other Intervention Names

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Bevacizumab-IRDye800CW

Eligibility Criteria

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Inclusion Criteria

1. Females aged ≥ 18 years
2. Scheduled for surgery for the treatment of endometriosis
3. WHO performance score of 0-2
4. Written informed consent

For female subjects who are of childbearing potential, are premenopausal with intact reproductive organs or are less than 2 years post-menopausal:
5. A negative serum pregnancy test prior to receiving the tracer
6. Willing to ensure that she or her partner uses effective contraception during the trial and for 6 months thereafter.

Exclusion Criteria

1. Medical or psychiatric conditions that compromise the patient's ability to give informed consent
2. Pregnancy
3. History of infusion reactions to Bevacizumab or other monoclonal antibody therapies
4. Significant renal, cardiac, or pulmonary disease (ASA III-IV)
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Medical Center Groningen

OTHER

Sponsor Role lead

Responsible Party

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G.M. van Dam

prof. dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gooitzen van Dam, prof dr

Role: PRINCIPAL_INVESTIGATOR

UMCG

Locations

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University Medical Center Groningen

Groningen, , Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Gooitzen van Dam, prof dr

Role: CONTACT

0503610183

Facility Contacts

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Go M. van Dam, MD, PhD

Role: primary

+31 50 361 0183

Other Identifiers

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2016/304

Identifier Type: -

Identifier Source: org_study_id

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