The primary objective of this study is to assess the diagnostic accuracy, in terms of sensitivity and negative predictive value, of preoperative CT lymphography as compared with conventional lymphoscintigraphy for SLN detection. Secondly, we aim to…
ID
Source
Brief title
Condition
- Head and neck therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The sensitivity and negative predictive value of CT lymphography as compared
with conventional lymphoscintigraphy for SLNB. In addition, the sensitivity and
negative predictive value for preoperative CT lymphography combined with
conventional preoperative lymphoscintigraphy.
Secondary outcome
• To compare the number of CT lymphographic detected SLNs with those detected
by means of 99mTc-nanocolloid lymphoscintigraphy on a per-subject basis.
• To compare the number of CT lymphographic detected higher-echelon nodes 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 CT
lymphography.
• Observing contralateral drainage patterns in lateralized tumors and compare
these patterns between CT lymphography and conventional 99mTc-nanocolloid
lymphoscintigraphy.
• To assess pairwise inter-observer agreements between CT lymphography and
conventional 99mTc-nanocolloid lymphoscintigraphy regarding preoperative SLN
detection.
Background summary
Cervical lymph node metastasis is the single most important prognostic factor
in head and neck squamous cell carcinoma (HNSCC), including oral cavity
squamous cell carcinoma (OSCC), and accurate detection of cervical lymph node
metastastes is critical for surgical and adjuvant therapy planning and
prognosis prediction. The sentinel lymph node (SLN) procedure is a diagnostic
staging procedure that is applied in a variety of tumour types, including
HNSCC. The 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 SLNs close to tumor sites
is hampered, since the injection site of the radiotracer, around the primary
tumor, produces a large hotspot on lymphoscintigraphy possibly hiding SLNs in
close proximity of the primary tumor (*shine through* effect). SLN imaging
using CT techniques might be more sensitive for detection of SNLs.
Study objective
The primary objective of this study is to assess the diagnostic accuracy, in
terms of sensitivity and negative predictive value, of preoperative CT
lymphography as compared with conventional lymphoscintigraphy for SLN
detection. Secondly, we aim to assess the diagnostic accuracy of preoperative
CT lymphography combined with conventional preoperative lymphoscintigraphy for
SLN detection.
Study design
1. A pilot study to optimize the CT lymphography imaging protocol and build
experience with the outcomes of CT lymphography (10 patients).
2. A prospective cohort study and a within-patient evaluation of CT
lymphography for identification of SLNs as compared to conventional 99mTc-
nanocolloid lymphoscintigraphy in patients with early-stage OSCC (84 patients).
Study burden and risks
Patients will undergo an additional CT lymphography after peritumoral
injections with lipiodol. The information obtained by CT lymphography may
provide helpful anatomical information of the SLN(s) for the surgeon, which may
help in harvesting the SLN(s), especially in cases where the SLN(s) are located
close to the injection site of the primary tumor. The extra administration of
0.5 mL lipiodol, followed by CT imaging, will not result in a significant
additional (radiation) burden for the patient.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all
of the following 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 tumour dimensions of >2 cm and <=4 cm with
DOI >10 mm), N0, M0.
3. Clinical nodal staging (N0) has been confirmed by negative results from
ultrasound guided fine needle aspiration cytology.
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 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.
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. Patient is incapacitated.
3. Patient is pregnant or lactating.
4. Previous allergic reaction after administration of a CT-contrast-agent for
contrast enhanced CT-imaging.
5. Patient is known with manifest hyperthyroidism.
6. The patient has clinical or radiological evidence of metastatic cancer to
the regional lymph nodes.
7. 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.
8. The patient is actively receiving systemic cytotoxic chemotherapy.
9. Patient is on immunosuppressive, anti-monocyte, or immunomodulatory
therapy.
10. Participation will result in unacceptable delay regarding oncological
treatment.
Design
Recruitment
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 |
|---|---|
| CCMO | NL72330.041.20 |