Ovarian CancerPhase 1/2OV-AP-ICG-IVNCT01834469
Imaging of Peritoneal Carcinomatosis From Ovarian Carcinoma Patients
A Phase 1/2 study testing iv injection of ICG in people with Ovarian Cancer and Peritoneal Carcinomatosis, run by Jules Bordet Institute at 1 site in Belgium.
Trial summary
The purpose of this study is to determine if NIF fluorescent imaging is an effective approach to detect the gross ovarian tumoral tissues and peritoneal implants in Ovarian cancer patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ovarian Cancer, Peritoneal Carcinomatosis
- What is being tested?
- iv injection of ICG
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBelgium
- Study dates
- Mar 2013to Oct 2014
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients (either newly diagnosed, or relapsing) with histo-pathological diagnosis of ovarian carcinoma and peritoneal carcinomatosis who are candidate for "open" surgery, either after neo-adjuvant chemotherapy (80-90% of the cases), or in "first intent".
- Informed consent form signed.
Who cannot join
- Age less than18 years old.
- Inability to give informed consent.
- History of allergy or hypersensitivity against the investigational product (its active substance or ingredients), to iodine or to shellfish.
- Apparent hyperthyroidism, autonomous thyroid adenoma, unifocal, multifocal or disseminated autonomies of the thyroid gland.
- Documented coronary disease.
- Advanced renal impairment (creatinine > 1,5mg/dl).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility Study of the (Intravenously Injected) Indocyanine Green (ICG) Imaging of Tumoral Implants in Patients With Peritoneal Carcinomatosis From Ovarian Carcinoma
The purpose of this study is to determine if NIF fluorescent imaging is an effective approach to detect the gross ovarian tumoral tissues and peritoneal implants in Ovarian cancer patients.
Read the detailed description
Primary objective:
Evaluation of the ability of NIR imaging to image and to detect the " viable " gross tumoral mass and/or peritoneal metastatic " implants " in women operated for ovarian carcinoma with peritoneal carcinomatosis after the IV injection of ICG ( which is approved for human use) the day before the operation.
Secondary objective:
Definition of the histological distribution (in the vessels, in the extravascular spaces, in specific cells) of IV injected ICG in the normal and pathological tissues (and, if any is demonstrated pre-operatively, in the nodes of these patients found fluorescent and removed).
however other goals of our project will be will be:
- to confirm that all dissected fluorescent tissue samples are malignant by histopathology.
- to study the histological distribution of ICG in these tumoral tissues.
- to investigate if there is any other florescent tissue in the peritoneal areas which surgeons could not detect any visible tumor implants.
- to distinguish by ICG distribution in between viable tumor tissue from fibrosis and necrosis caused by chemotherapy which is normally difficult to be defined in scars which are routinely removed, but if we could identify the viable tumor tissue by NIF imaging in the operation room, surgeons can avoid dissecting benign scars in the future.
Hopefully ICG will be able to help, firstly, in the scoring of the peritoneal cancer index (PCI) enhancing the detection of small nodules which were undetected by normal visualization allowing a more 'complete' surgical treatment of the disease and secondarily, in the staging of these patients with the potential to upgrade patients from stage I/II to stage III in cases where fluoroscopy would allow to detect unknown minimal peritoneal carcinomatosis.
Methodology:
The day before the operation:
ICG 0.25 mg/kg will be given as an iv injection the day before the operation.
In the operating room:
When the patient will be opened, the surgeons will (under "conventional" video control) search ("in an orderly fashion") and establish "as usual" the presence of "gross" tumoral mass, of metastatic deposits and of "scars" at the level of the peritoneal surfaces. NIR imaging will be acquired during these maneuvers and fluorescent structures and/or foci will be anatomically defined by the surgeons.
The operation will be then continued as usual but each anatomical piece will be controlled "ex vivo" for its fluorescent character or not. All fluorescent foci on these anatomical pieces will be identified as such by a mark and/or by a "suture".
If lymph nodes were suspected to be metastatic (for instance on the basis of the PET-CT with 18F-DG performed before surgery), they will be searched, (optionally controlled in vivo for their visibility using NIR camera)and dissected.
- Conditions
- Ovarian Cancer, Peritoneal Carcinomatosis
- Being tested
- iv injection of ICG
- Keywords
- Ovarian,metastasis
- Medical subject headings
- Ovarian Neoplasms, Peritoneal Neoplasms, Krukenberg Tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iv injection of ICGDrug
An iv injection will be performed for the ovarian cancer patient before the operation.
| Study group | Role | What they receive |
|---|---|---|
| ICG NIR imaging | Other | see Summary and description iv injection of ICG Receives: Drug: iv injection of ICG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility study of the (intravenously injected) ICG imaging of tumoral implants in patients with peritoneal carcinomatosis from ovarian carcinoma
Evaluation of the feasibility of NIF imaging to detect tumoral implants in patients with peritoneal carcinomatosis from ovarian carcinoma, the efficacy of this approach will be confirmed by histological test of the dissected tissue.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2013 (estimated)
- Study startMar 2013
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jules Bordet Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isabelle Veys, MD, Principal investigator, Surgeon in Jules Bordet InstituteGabriel Liberale, MD, Study chair, Surgeon in Jules Bordet Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01834469
- Sponsor's protocol ID
- 2083
- Other IDs
- 2013-000276-15
- Acronym
- OV-AP-ICG-IV
- Status last verified
- Jul 2014
- First submitted
- 14 Apr 2013
- Last updated
- 15 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of the (Intravenously Injected) Indocyanine Green (ICG) Imaging of Tumoral Implants in Patients With Peritoneal Carcinomatosis From Ovarian Carcinoma
- ClinicalTrials.gov ID
- NCT01834469
- Acronym / sponsor ID
- OV-AP-ICG-IV / 2083
- Conditions
- Ovarian Cancer, Peritoneal Carcinomatosis
- Keywords
- Ovarian,metastasis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Jules Bordet InstituteUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 18 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if NIF fluorescent imaging is an effective approach to detect the gross ovarian tumoral tissues and peritoneal implants in Ovarian cancer patients.
Detailed description
Primary objective:
Evaluation of the ability of NIR imaging to image and to detect the " viable " gross tumoral mass and/or peritoneal metastatic " implants " in women operated for ovarian carcinoma with peritoneal carcinomatosis after the IV injection of ICG ( which is approved for human use) the day before the operation.
Secondary objective:
Definition of the histological distribution (in the vessels, in the extravascular spaces, in specific cells) of IV injected ICG in the normal and pathological tissues (and, if any is demonstrated pre-operatively, in the nodes of these patients found fluorescent and removed).
however other goals of our project will be will be:
- to confirm that all dissected fluorescent tissue samples are malignant by histopathology.
- to study the histological distribution of ICG in these tumoral tissues.
- to investigate if there is any other florescent tissue in the peritoneal areas which surgeons could not detect any visible tumor implants.
- to distinguish by ICG distribution in between viable tumor tissue from fibrosis and necrosis caused by chemotherapy which is normally difficult to be defined in scars which are routinely removed, but if we could identify the viable tumor tissue by NIF imaging in the operation room, surgeons can avoid dissecting benign scars in the future.
Hopefully ICG will be able to help, firstly, in the scoring of the peritoneal cancer index (PCI) enhancing the detection of small nodules which were undetected by normal visualization allowing a more 'complete' surgical treatment of the disease and secondarily, in the staging of these patients with the potential to upgrade patients from stage I/II to stage III in cases where fluoroscopy would allow to detect unknown minimal peritoneal carcinomatosis.
Methodology:
The day before the operation:
ICG 0.25 mg/kg will be given as an iv injection the day before the operation.
In the operating room:
When the patient will be opened, the surgeons will (under "conventional" video control) search ("in an orderly fashion") and establish "as usual" the presence of "gross" tumoral mass, of metastatic deposits and of "scars" at the level of the peritoneal surfaces. NIR imaging will be acquired during these maneuvers and fluorescent structures and/or foci will be anatomically defined by the surgeons.
The operation will be then continued as usual but each anatomical piece will be controlled "ex vivo" for its fluorescent character or not. All fluorescent foci on these anatomical pieces will be identified as such by a mark and/or by a "suture".
If lymph nodes were suspected to be metastatic (for instance on the basis of the PET-CT with 18F-DG performed before surgery), they will be searched, (optionally controlled in vivo for their visibility using NIR camera)and dissected.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICG NIR imaging | Other | Drug: iv injection of ICGsee Summary and description iv injection of ICG |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients (either newly diagnosed, or relapsing) with histo-pathological diagnosis of ovarian carcinoma and peritoneal carcinomatosis who are candidate for "open" surgery, either after neo-adjuvant chemotherapy (80-90% of the cases), or in "first intent".
- Informed consent form signed.
Key exclusion criteria (6 listed)
- Age less than18 years old.
- Inability to give informed consent.
- History of allergy or hypersensitivity against the investigational product (its active substance or ingredients), to iodine or to shellfish.
- Apparent hyperthyroidism, autonomous thyroid adenoma, unifocal, multifocal or disseminated autonomies of the thyroid gland.
- Documented coronary disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iv injection of ICGAn iv injection will be performed for the ovarian cancer patient before the operation. | Drug | ICG NIR imaging |
Primary outcome
Feasibility study of the (intravenously injected) ICG imaging of tumoral implants in patients with peritoneal carcinomatosis from ovarian carcinoma
Time frame: 1 year
Evaluation of the feasibility of NIF imaging to detect tumoral implants in patients with peritoneal carcinomatosis from ovarian carcinoma, the efficacy of this approach will be confirmed by histological test of the dissected tissue.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabelle Veys, MD principal investigator
Surgeon in Jules Bordet Institute
Gabriel Liberale, MD study chair
Surgeon in Jules Bordet Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing iv injection of ICG in people with Ovarian Cancer and Peritoneal Carcinomatosis, run by Jules Bordet Institute at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility study of the (intravenously injected) ICG imaging of tumoral implants in patients with peritoneal carcinomatosis from ovarian carcinoma (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2014; AzTrials last refreshed its copy on 8 Nov 2026.