Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ended
Participants planned
10
Countries
1
Sites
1
Endometrial cancer, uterine cancer
to evaluate feasibility of 68Ga-tilmanocept PET/CT for SLN mapping in patients with stage I-II high/high-intermediate risk endometrial cancer
Key facts
- Sponsor
- Universitair Medisch Centrum Utrecht
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 15 Nov 2024 → 9 Apr 2026
- Decision date (initial)
- 2024-11-15
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-516708-40-00
- EudraCT number
- 2022-001237-37
- ClinicalTrials.gov
- NCT05446324
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Diagnosis
to evaluate feasibility of 68Ga-tilmanocept PET/CT for SLN mapping in patients with stage I-II high/high-intermediate risk endometrial cancer
Secondary objectives 1
- - To investigate the correlation between SLN detection rate and anatomical location of SLNs with preoperative 68Ga-tilmanoceptPET/CT versus intraoperative ICG with NIR fluorescence; - To assess pathological status of the SLNs: tumour negative, macrometastasis (diameter >2.0 mm), micrometastasis (diameterbetween 0.2 and 2.0 mm) or isolated tumour cells (diameter <0.2 mm or individual tumour cells); - To investigate adverse events related to SLN mapping with 68Ga-tilmanocept PET/CT up to one hour post-PET/CT (graded byCommon Terminology Criteria for Adverse Events (CTCAE) v5.0).
Conditions and MedDRA coding
Endometrial cancer, uterine cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | PT | 10014739 | Endometrial cancer stage II | 100000004864 |
| 21.0 | PT | 10014738 | Endometrial cancer stage I | 100000004864 |
Regulatory references
- Scientific advice from competent authorities
- Central Committee On Research Involving Human Subjects
- Plan to share IPD
- No
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- - Clinical FIGO 2012 stage I-II high/high-intermediate risk endometrial cancer; - Scheduled for robot-assisted full pelvic and para-aortic staging; - Age ≥18 years and able to provide informed consent.
Exclusion criteria 1
- - Pregnancy or current breastfeeding (in women at a ferile age with a possibility of prenancy, confirmation by a pregnancy test is current standard of care); - Prior severe allergic reaction to iodine; - Severe renal insufficiency (stage 3 or 4); - Clinical or radiological evidence of metastatic disease.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Primary endpoint is the feasibility of the SLN procedure using 68-Ga tilmanocept PET/CT in patients with high/high-intermediate riskendometrial cancer. The feasibility is assessed by the SLN detection rate of 68Ga-tilmanocept PET/CT. The SLN detection rate of PET/CT is defined as the detection of a PET-avid node.
Secondary endpoints 2
- - To investigate the correlation between SLN detection rate and anatomical location of SLNs with preoperative 68Ga-tilmanoceptPET/CT versus intraoperative ICG with NIR fluorescence; - To assess pathological status of the SLNs: tumour negative, macrometastasis (diameter >2.0 mm), micrometastasis (diameterbetween 0.2 and 2.0 mm) or isolated tumour cells (diameter <0.2 mm or individual tumour cells);
- Adverse events related to SLN mapping with 68Ga-tilmanocept PET/CT up to one hour post-PET/CT (graded by CommonTerminology Criteria for Adverse Events (CTCAE) v5.0).
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
SUB170788 · Substance
- Active substance
- Gallium (68GA) Chloride
- Pharmaceutical form
- RADIONUCLIDE GENERATOR
- Route of administration
- INTRACERVICAL USE
- Max daily dose
- 10 MBq megabecquerel(s)
- Max total dose
- 10 MBq megabecquerel(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB119775 · Substance
- Active substance
- Tilmanocept
- Pharmaceutical form
- KIT FOR RADIOPHARMACEUTICAL PREPARATION
- Route of administration
- INTRACERVICAL USE
- Max daily dose
- 0.05 mg milligram(s)
- Max total dose
- 0.05 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Universitair Medisch Centrum Utrecht
- Sponsor organisation
- Universitair Medisch Centrum Utrecht
- Address
- Heidelberglaan 100
- City
- Utrecht
- Postcode
- 3584 CX
- Country
- Netherlands
Scientific contact point
- Organisation
- Universitair Medisch Centrum Utrecht
- Contact name
- Gerestein
Public contact point
- Organisation
- Universitair Medisch Centrum Utrecht
- Contact name
- Gerestein
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ended | 10 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Universitair Medisch Centrum Utrecht
Gyneacological Oncology, Heidelberglaan 100, 3584 CX, Utrecht
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Netherlands | 2024-11-15 | 2024-11-15 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 5 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-516708-40-00_for publication | 1.2 |
| Recruitment arrangements (for publication) | K1_blank document | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults_For publication | 1.2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SPC Galliapharm | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SPC Lymphoseek | 2 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-09 | Netherlands | Acceptable 2024-11-15
|
2024-11-15 |