The primary objective of this feasibility study is to investigate the detection rate of SLNs using MR lymphography.
ID
Source
Brief title
Condition
- Head and neck therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter will be the detection rate of sentinel lymph nodes
with MR lymphography compared to conventional sentinel lymph node scintigraphy
using 99mTc-nanocolloid.
Secondary outcome
• To compare the number of MR lymphographic detected SLNs with those detected
by means of 99mTc-nanocolloid lymphoscintigraphy on a per-subject basis.
• To compare histopathologic assessment (presence or absence of metastasis) of
the excised lymph node(s) detected by conventional preoperative
99mTc-nanocolloid lymphoscintigraphy and intraoperative gammaprobe
localization, with the SLNs identified by means of preoperative MR lymphography.
• Observing contralateral drainage patterns in lateralized tumors and compare
these patterns between MR lymphography and conventional 99mTc-nanocolloid
lymphoscintigraphy.
• To assess pairwise inter-observer agreements between MR lymphography and
conventional 99mTc-nanocolloid lymphoscintigraphy regarding preoperative SLN
detection.
Background summary
Cervical lymph node metastasis is the single most important prognostic factor
in oral cavity squamous cell carcinoma (OSCC), and accurate detection of
cervical lymph node metastases is critical for surgical and adjuvant therapy
planning and prognosis prediction. The sentinel lymph node (SLN) is the first
draining lymph node from the tumor, which is most likely to harbour metastases.
The histopathological status of the SLN should reflect the histopathological
status of the rest of the nodal basin, and additional treatment of the nodal
basin (e.g., surgery) should be performed in case of metastatic involvement of
the SLN. Detecting of SLNs close to tumor sites is hampered in procedures using
99mTc-nanocolloids due to injection site (around the primary tumor) producing a
large hotspot on lymphoscintigraphy possibly hiding SLNs in the close proximity
of the primary tumor (''shine through''). Sentinel lymph node imaging using MRI
techniques might be more sensitive for detection of SLNs.
Study objective
The primary objective of this feasibility study is to investigate the detection
rate of SLNs using MR lymphography.
Study design
The proposed feasibility study is a within-patient evaluation of MR
lymphography for identification of sentinel lymph nodes in early stage oral
cavity carcinoma and compared imaging results to lymphoscintigraphy using
99mTc-nanocolloid with histopathology as the reference standard.
Study burden and risks
Patients will undergo an additional MR lymphography with a duration of 30
minutes after receiving peritumoral injections with gadolinium-based contrast
agent. The additional anatomical imaging with MRI might lead to additional
detection of sentinel lymph nodes without the radiation burden that is
necessary for 99mTc-nanocolloid SPECT-CT imaging that is routinely performed.
The extra administration of gadolinium-based contrast agend, followed by MR
imaging, will not result in a significant additional (radiation) burden for the
patient.
Heidelberglaan 100
Utrecht 3584CX
NL
Heidelberglaan 100
Utrecht 3584CX
NL
Listed location countries
Age
Inclusion criteria
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, and is stage 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 3: TNM Staging).
3. Clinical nodal staging (N0) has been confirmed by negative results from CT,
MRI, PET/CT and/or ultrasound guided fine needle aspiration cytology within 30
days of the SLNB procedure.
4. The patient is a candidate for transoral excision and sentinel lymph node
biopsy.
5. The patient has given informed consent for a surgical procedure regarding
his/her oncological treatment.
6. Patients with prior malignancy 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 4: Performance
Status Criteria).
Exclusion criteria
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 pregnant.
3. Patient is incapacitated.
4. Previous allergic reaction after administration of a gadolinium-based
contrast agent for contrast enhanced MR imaging.
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 preclude reasonable surgical dissection for this trial, or
radiotherapy to the neck.
7. The patient is actively receiving systemic cytotoxic chemotherapy.
8. Patient is on immunosuppressive, anti-monocyte, or immunomodulatory therapy.
9. Patient has severe renal impairment (eGFR<30).
10. Participation will result in unacceptable delay regarding oncological
treatment.
11. Patients with known claustrophobia, who are as a consequence unable to
undergo MR imaging.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2021-003554-23-NL |
| CCMO | NL78145.041.21 |