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…
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 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 outcome
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.
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.
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.
To assess pairwise inter-observer agreements between 68Ga-Tilmanocept PET-CT
and 99mTc-Tilmanocept lymphoscintigraphy regarding preoperative SLN detection.
Background summary
Sentinel lymph node biopsy (SLNB) is a diagnostic staging procedure that is
applied in a variety of tumor types, including oral cavity squamous cell
carcinoma (OSCC). The procedure aims to identify the first draining lymph
node(s) (SLN(s)), which is most likely to harbour metastases. The
histopathological status of the SLN reflects 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). Because of higher resolution 68Ga-Tilmanocept
PET/CT-imaging may limit the *shine through* effect and may provide improved
anatomic localization of SLNs as compared to conventional lymphoscintigraphy.
Therefore, 68Ga-Tilmanocept PET/CT might be more sensitive for detection of
SLNs and might improve differentiation between SLNs and second echelon lymph
nodes.
Study objective
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.
Study design
1. A pilot study to optimize the 68Ga-Tilmanocept PET/CT imaging protocol and
build experience with the outcomes of 68Ga-Tilmanocept PET/CT (10 patients).
2. A prospective cohort study and a within-patient evaluation of
68Ga-Tilmanocept PET/CT for identification of SLNs as compared to conventional
lymphoscintigraphy in patients with early-stage OSCC (84 patients).
Intervention
Patients will undergo additional PET/CT imaging following peritumoral
injections of 10 MBq 68Ga-Tilmanocept. Results of 68Ga-Tilmanocept PET/CT
imaging will be compared to results of conventional lymphoscintigraphy
(including SPECT-CT) using 99mTc-Tilmanocept.
Study burden and risks
Patients will undergo additional peritumoral injections and two PET/CT-imaging
with a duration of 5 minutes. 68Ga-Tilmanocept PET/CT may identify SLNs more
reliable than routinely used lymphoscintigraphy using 99mTc-Tilmanocept.
Information obtained from 68Ga-Tilmanocept PET/CT may be helpful in harvesting
SLNs. The extra administration of 10 MBq 68Ga-Tilmanocept is considered an
acceptable radiation burden to the patient. Adverse reactions after injection
of radiolabelled Tilmanocept rarely occur.
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.
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
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
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, hy-popharynx, and larynx.
2. The patient is incapacitated.
3. The patient has had a previous allergic reaction after administration of a
radionuclide trac-er.
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.
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 | EUCTR2019-004914-32-NL |
| CCMO | NL71558.041.20 |