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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Rheinische Friedrich-Wilhelms-Universitaet Bonn

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Female

Therapeutic area

Analytical,Diagnostic,Therapeutic Techniques and Equipment [E]-Surgical Procedures, Operative [E04], Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]

Trial duration

10 Jun 2025 → ongoing

Decision date (initial)

2024-09-10

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

photonamic GmbH & Co. KG (IMP) · Kommission für Klinische Studien, Rheinische Friedrich-Wilhelms-Universität Bonn

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy, Diagnosis

To evaluate the efficacy of intraoperative imaging using 5-ALA to detect ovarian cancer tumour manifestations that would not have been identified as such by normal light and palpation and would not have been scheduled for resection.

Secondary objectives 1

1. To evaluate the application of intraoperative imaging using 5-ALA to detect ovarian cancer tumour manifestations regarding Safety, Positive predictive value, Sensitivity, Patient-related false positive rate, Lesion-related false positive rate, Peritoneal Cancer Index (PCI)

Conditions and MedDRA coding

Ovarian Cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Written informed consent to participate in this clinical trial in accordance with local regulations and the ethical review board governing this clinical trial
2. Female
3. Age ≥ 18 years
4. Confirmed or suspected ovarian cancer or ovarian cancer recurrence
5. Planned surgical treatment by staging or debulking laparotomy at the Department of Gynecology and Gynecologic Oncology at the University Hospital Bonn. Interval debulking operations after previous neoadjuvant chemotherapy are also included.

Exclusion criteria 13

1. Subject without legal capacity who is unable to understand the nature, scope, significance and consequences of this clinical trial
2. Subjects with a physical or psychiatric condition which at the investigator’s discretion may put the subject at risk, may confound the trial results, or may interfere with the subject’s participation in this clinical trial
3. Simultaneous participation in another surgical clinical trial, or participation in a clinical trial taking an investigational product, up to 30 days after last IMP intake in that clinical trial
4. Known or persistent abuse of medication, drugs or alcohol
5. Current (positive pregnancy test, e.g. beta-hCG test in serum) or planned pregnancy or nursing women
6. Fertility-preserving surgical therapy
7. Presence of another type of cancer in the final histology
8. Preoperative classification of the patient as inoperable
9. Known history of hypersensitivity to the investigational drug or to drugs with a similar chemical structure
10. Known history of hypersensitivity to porphyrins
11. Known secondary diagnoses that present a risk when using the IMP, in particular acute and chronic porphyria
12. Restricted kidney function (GFR < 50 ml/min)
13. Restricted liver function (bilirubin / AST/ALT > 3x ULN)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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 endpoints 8

1. Assessment of active-substance-specific adverse reactions and serious adverse reactions of CTCAE grades 3, 4, and 5
2. 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
3. Proportion of 5-ALA positive and histologically positive lesions out of all 5-ALA positive lesions
4. Proportion of 5-ALA positive and histologically positive lesions out of all histologically positive lesions
5. Proportion of patients in whom all 5-ALA positive lesions are histologically negative
6. Proportion of 5-ALA positive but histologically negative lesions among all 5-ALA positive lesions only
7. PCI change by considering additionally resected 5-ALA positive and histologically confirmed ovarian cancer tumour manifestations
8. Change of FIGO classification considering additionally resected 5-ALA positive and histologically confirmed ovarian cancer tumour manifestations

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Rheinische Friedrich-Wilhelms-Universitaet Bonn

Sponsor organisation

Rheinische Friedrich-Wilhelms-Universitaet Bonn

Address

Venusberg-Campus 1, Venusberg Venusberg

City

Bonn

Postcode

53127

Country

Germany

Scientific contact point

Organisation

Rheinische Friedrich-Wilhelms-Universitaet Bonn

Contact name

Prof. Dr. Alexander Mustea

Public contact point

Organisation

Rheinische Friedrich-Wilhelms-Universitaet Bonn

Contact name

Prof. Dr. Alexander Mustea

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 6 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications