5-Aminolevulinic Acid (5-ALA) for Intraoperative Imaging in Patients with Ovarian Cancer – a Single Center Feasibility Study (ILLUMINATE)

Conditions

Ovarian Cancer

Brief summary

Percentage of patients with at least one 5-ALA positive and histologically positive ovarian cancer tumour manifestation that was not scheduled for resection based on the surgical plan established under standard conditions (normal light and palpation).

Detailed description

Assessment of active-substance-specific adverse reactions and serious adverse reactions of CTCAE grades 3, 4, and 5, Perioperative morbidity (30 days); Comparison with historical data on perioperative morbidity at the study site applying the Memorial Sloan Kettering Cancer Center (MSKCC) Surgical Secondary Events (SSE) system, Proportion of 5-ALA positive and histologically positive lesions out of all 5-ALA positive lesions, Proportion of 5-ALA positive and histologically positive lesions out of all histologically positive lesions, Proportion of patients in whom all 5-ALA positive lesions are histologically negative, Proportion of 5-ALA positive but histologically negative lesions among all 5-ALA positive lesions only, PCI change by considering additionally resected 5-ALA positive and histologically confirmed ovarian cancer tumour manifestations, Change of FIGO classification considering additionally resected 5-ALA positive and histologically confirmed ovarian cancer tumour manifestations

Related papers

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Interventions

DRUGGliolan 30 mg/ml powder for oral solution.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Percentage of patients with at least one 5-ALA positive and histologically positive ovarian cancer tumour manifestation that was not scheduled for resection based on the surgical plan established under standard conditions (normal light and palpation).	—

Secondary

Measure	Time frame
Assessment of active-substance-specific adverse reactions and serious adverse reactions of CTCAE grades 3, 4, and 5, Perioperative morbidity (30 days); Comparison with historical data on perioperative morbidity at the study site applying the Memorial Sloan Kettering Cancer Center (MSKCC) Surgical Secondary Events (SSE) system, Proportion of 5-ALA positive and histologically positive lesions out of all 5-ALA positive lesions, Proportion of 5-ALA positive and histologically positive lesions out of all histologically positive lesions, Proportion of patients in whom all 5-ALA positive lesions are histologically negative, Proportion of 5-ALA positive but histologically negative lesions among all 5-ALA positive lesions only, PCI change by considering additionally resected 5-ALA positive and histologically confirmed ovarian cancer tumour manifestations, Change of FIGO classification considering additionally resected 5-ALA positive and histologically confirmed ovarian cancer tumour manifestati	—

Measure

Time frame

Assessment of active-substance-specific adverse reactions and serious adverse reactions of CTCAE grades 3, 4, and 5, Perioperative morbidity (30 days); Comparison with historical data on perioperative morbidity at the study site applying the Memorial Sloan Kettering Cancer Center (MSKCC) Surgical Secondary Events (SSE) system, Proportion of 5-ALA positive and histologically positive lesions out of all 5-ALA positive lesions, Proportion of 5-ALA positive and histologically positive lesions out of all histologically positive lesions, Proportion of patients in whom all 5-ALA positive lesions are histologically negative, Proportion of 5-ALA positive but histologically negative lesions among all 5-ALA positive lesions only, PCI change by considering additionally resected 5-ALA positive and histologically confirmed ovarian cancer tumour manifestations, Change of FIGO classification considering additionally resected 5-ALA positive and histologically confirmed ovarian cancer tumour manifestati

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Countries

Germany

Outcome results

None listed