Intraoperative detection of ovarian cancer metastases using near-infrared fluorescence imaging and indocyanine green
| ISRCTN | ISRCTN16945066 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16945066 |
| Secondary identifying numbers | P10.001 |
- Submission date
- 19/08/2014
- Registration date
- 11/09/2014
- Last edited
- 26/06/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
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
Contact information
Scientific
Albinusdreef 2
Leiden
2333 ZA
Netherlands
Study information
| 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 |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Intraoperative detection of ovarian cancer metastases using near-infrared fluorescence imaging and indocyanine green: a open-label, exploratory, non-randomised clinical trial |
| Study 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 |
| 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 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 15 |
| 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 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
2333 ZA
Netherlands
Sponsor information
Hospital/treatment centre
Albinusdreef 2
Leiden
2333 ZA
Netherlands
| Website | http://www.lumc.nl |
|---|---|
"ROR" |
https://ror.org/05xvt9f17 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 25/06/2015 | Yes | No |
