ISRCTN - ISRCTN16945066: Intraoperative detection of ovarian cancer metastases using near-infrared fluorescence imaging and indocyanine green

Plain English Summary

Background and study aims
Ovarian cancer is one of the most common cancers among women. Unfortunately, because early symptoms can be vague and somewhat similar to other conditions, it is often not diagnosed until it has reached an advanced stage and spread (metastasized) to other areas of the body. Surgery is useful in two ways; to remove tumors and to discover how far the cancer has spread (known as tumor staging). It is sometimes difficult to see all the tumors until surgery has begun and finding them all even during surgery can be a challenge, particularly when trying to find smaller ones. However, a new method, near-infrared fluorescent (NIRF) imaging has been developed that can see ovarian tumor tissue during surgery. In early studies it has been shown that ovarian cancer can be identified using NIRF imaging and a special dye called near-infrared fluorescent dye indocyanine green. This is because the dye tends to accumulate in tumors much more readily than they do in normal tissues (called the enhanced permeability and retention - or EPR - effect). We want to see how many tumors are seen using the new technique.

Who can participate?
Adult women aged at least 18 years either diagnosed with, or suspected to have, ovarian cancer and due for tumor staging or cytoreductive surgery (surgery to remove the tumor(s)) .

What does the study involve?
Ovarian cancer patients have indocyanine green given to them intravenously during surgery and NIRF performed to make the tumors easier to see. The number of tumors are then counted and a health professional (pathologist) then looks at the tumors that are removed to see how advanced the disease has become.

What are the possible benefits and risks of participating?
Possible benefits include finding more tumors that would otherwise be the case during surgery. A possible risk is an allergic reaction to indocyanine green. However, this is very rare (< 1 out of 20.000) and can be managed by the anaesthesiologist.

Where is the study run from?
Leiden University Medical Center (Netherlands)

When is the study starting and how long is it expected to run for?
October 2012 to October 2015

Who is funding the study?
Leiden University Medical Center (Netherlands)

Who is the main contact?
Dr Alexander Vahrmeijer
a.l.vahrmeijer@lumc.nl
Dr. Katja Gaarenstroom
k.n.gaarenstroom@lumc.nl

Study website

Contact information

Type

Scientific

Contact name

Dr Alexander Vahrmeijer

ORCID ID

Contact details

Albinusdreef 2
Leiden
2333 ZA
Netherlands

Additional identifiers

EudraCT/CTIS number

IRAS number

ClinicalTrials.gov number

Protocol/serial number

P10.001

Study information

Scientific title

Intraoperative detection of ovarian cancer metastases using near-infrared fluorescence imaging and indocyanine green: a open-label, exploratory, non-randomised clinical trial

Acronym

GREENLIGHT

Study hypothesis

Near-infrared fluorescence imaging using indocyanine green can assist in the intraoperative detection of ovarian cancer metastases

Ethics approval(s)

Ethics Committee of the Leiden University Medical Center, 27/07/2012, ref: P10.001/NV/nv

Study design

Open-label exploratory non-randomised clinical trial

Primary study design

Interventional

Secondary study design

Non randomised study

Study setting(s)

Hospital

Study type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Ovarian cancer

Intervention

Intravenous administration of 20 mg Indocyanine Green

Intervention type

Other

Primary outcome measure

The number of intraoperative detected metastases using near-infrared fluorescence imaging and indocyanine green.This will be measured during surgery. When new anatomical sites are exposed during surgery, color images and NIR fluorescent images are obtained. After surgery, the Pathologist will perform histological assessment of the resected lesions for tumor status.

Secondary outcome measures

1. Sensitivity and specificity of detected fluorescent hotspots
2. Concordance between fluorescence signal and pathology assessment

Sensitivity and specificity of the fluorescent signal will be calculated after tumor status of theresected lesions is assessed. Concordance will also be calculated after surgery with theobtained information on fluorescence signal and tumor status of the resected lesions.

Overall study start date

01/10/2012

Overall study end date

01/10/2015

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. All patients diagnosed with or suspected for ovarian cancer planned for staging or cytoreductive surgery
2. Age >18 years old

Participant type(s)

Patient

Age group

Adult

Lower age limit

18 Years

Sex

Female

Target number of participants

15

Participant exclusion criteria

1. Renal impairment (defined as eGFR<55)
2. History of allergy to iodine, shellfish or indocyanine green
3. Patient pregnant or lactating

Recruitment start date

01/10/2012

Recruitment end date

01/10/2015

Locations

Countries of recruitment

Netherlands

Study participating centre

Albinusdreef 2
Leiden
2333 ZA
Netherlands

Sponsor information

Organisation

Leiden University Medical Center (Netherlands)

Sponsor details