Sentinel lymph node (SLN) detection in early oral cancer using Gallium-68-Tilmanocept PET/CT.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Universitair Medisch Centrum Utrecht

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]

Decision date (initial)

2025-04-18

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

KWF Dutch Cancer Society

External identifiers

EU CT number

2025-521682-27-00

EudraCT number

2019-004914-32

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Diagnosis

The primary objective of this study is to assess the diagnostic accuracy, in terms of sensitivity and negative predictive value, of preoperative 68Ga-Tilmanocept PET/CT combined with conventional lymphoscintigraphy for SLN detection. Besides, we aim to compare the diagnostic accuracy of preoperative 68Ga-Tilmanocept PET/CT alone with conventional preoperative lymphoscintigraphy alone.

Secondary objectives 4

1. To compare the number of 68Ga-Tilmanocept PET-CT detected SLNs with those detected by means of 99mTc-Tilmanocept lymphoscintigraphy on a per-subject basis.
2. To compare histopathologic assessment (presence or absence of metastasis) of the excised lymph node(s) detected by conventional preoperative 99mTc-Tilmanocept lymphoscintigraphy and intraoperative gammaprobe localization, with the SLNs identified by means of preoperative 68Ga-Tilmanocept PET-CT.
3. Observing contralateral drainage patterns in lateralized tumors and compare these patterns between of 68Ga-Tilmanocept PET-CT and 99mTc-Tilmanocept lymphoscintigraphy, especially in case of a histopathological positive sentinel node.
4. To assess pairwise inter-observer agreements between 68Ga-Tilmanocept PET-CT and 99mTc-Tilmanocept lymphoscintigraphy regarding preoperative SLN detection.

Conditions and MedDRA coding

Oral cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. The patient has provided written informed consent authorization before participating in the study.
2. The patient has a diagnosis of primary oral squamous cell carcinoma that is anatomically located in: mucosal lip, buccal mucosa, lower alveolar ridge, upper alveolar ridge, retromolar gingival (retromolar trigone), floor-of-the-mouth, hard palate or oral (mobile) tongue.
3. Clinical TNM-stage is T1-T2 and T3 (only when T3 is assessed based on tumor dimensions of >2 cm and ≤4 cm with DOI >10 mm), N0, M0 (see Appendix 6: TNM Staging).
4. Clinical nodal staging (N0) has been confirmed by negative results from ultrasound guided fine needle aspiration cytology within 30 days of the SLN procedure.
5. The patient is a candidate for transoral excision.
6. Patients with prior malignancy of the head and neck area are allowed, provided the patient meets both of the following criteria: • Underwent potentially curative therapy for all prior head and neck malignancies and is deemed low risk for recurrence; and • No head and neck malignancy for the past five years and no evidence of recurrence.
7. The patient is ≥18 years of age at the time of consent.
8. The patient has an ECOG status of Grade 0 – 2 (see Appendix 7: Performance Status Criteria).

Exclusion criteria 8

1. The patient has a diagnosis of squamous cell carcinoma of the head and neck in the following anatomical areas: non-mobile base of the tongue, oropharynx, nasopharynx, hypopharynx, and larynx.
2. The patient is incapacitated.
3. The patient has had a previous allergic reaction after administration of a radionuclide tracer.
4. The patient has had other nuclear imaging studies, conducted within 2 days (48 hours) of injection.
5. The patient has clinical or radiological evidence of metastatic cancer to the regional lymph nodes.
6. The patient has a history of neck dissection, or gross injury to the neck that would pre-clude reasonable surgical dissection for this trial, or radiotherapy to the neck.
7. The patient is actively receiving systemic cytotoxic chemotherapy.
8. The patient is on immunosuppressive, anti-monocyte, or immunomodulatory therapy.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The sensitivity and negative predictive value of 68Ga-Tilmanocept PET/CT combined with conventional lymphoscintigraphy for SLNB. Furthermore, the sensitivity and negative predictive value for preoperative 68Ga-Tilmanocept PET/CT alone will be compared with conventional preoperative lymphoscintigraphy alone.

Secondary endpoints 4

1. To compare the number of 68Ga-Tilmanocept PET-CT detected SLNs with those detected by means of 99mTc-Tilmanocept lymphoscintigraphy on a per-subject basis.
2. To compare histopathologic assessment (presence or absence of metastasis) of the excised lymph node(s) detected by conventional preoperative 99mTc-Tilmanocept lymphoscintigraphy and intraoperative gammaprobe localization, with the SLNs identified by means of preoperative 68Ga-Tilmanocept PET-CT.
3. Observing contralateral drainage patterns in lateralized tumors and compare these patterns between of 68Ga-Tilmanocept PET-CT and 99mTc-Tilmanocept lymphoscintigraphy, especially in case of a histopathological positive sentinel node.
4. To assess pairwise inter-observer agreements between 68Ga-Tilmanocept PET-CT and 99mTc-Tilmanocept lymphoscintigraphy regarding preoperative SLN detection.

Investigational products

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

Test 2

Comparator 2

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

Prof. dr. R. de Bree

Public contact point

Organisation

Universitair Medisch Centrum Utrecht

Contact name

Prof. dr. R. de Bree

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Corrective measures 1 · Art. 77 CTR

Results and documents

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

Documents 8 files

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

Application history

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