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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN16945066

Enrollment

Registered

2014-09-11

Start date

2012-10-01

Completion date

Unknown

Last updated

2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian cancer Cancer

Interventions

Intravenous administration of 20 mg Indocyanine Green

Eligibility

Sex/Gender

Female

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Primary

Measure	Time frame
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.	—

Countries

Netherlands

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 4, 2026