To explore the feasibility of sentinel lymph node identification by SPIO injection followed by MRI in head-and-neck cancer patients.
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms benign
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Feasibility of SPIO-enhanced MRI for SN detection in oral cancer patients:
- To optimize dose of SPIO injection
- To optimize the timing of MRI
- To assess whether SNs detected by conventional 99mTC-nanocollloid injection
and SPECT-CT are concordant with those visualized by SPIO injection and MRI
Secondary outcome
- To assess the distribution of SPIO within a lymph node by comparing in vivo
MR-images and histopathological staining
Background summary
Head-and-neck cancer (HNC) mostly comprises tumors in the oral cavity, pharynx
& larynx. Worldwide, HNC accounts for more than 650.000 cases annually. The
main treatment modalities are surgery and radiotherapy. Despite modern imaging
methods, up to 30% of HNC patients with a clinically and radiologically
negative neck (cN0) appear to have metastases. Therefore, elective radiotherapy
target volume in HNC includes the whole neck, often bilaterally. This results
in overtreatment of at least 70% of patients. Since the elective target is in
close proximity to critical anatomical structures (e.g. salivary glands,
swallowing muscles, thyroid gland and large blood vessels), the effect of
treatment has a negative impact on the quality-of-life in HNC survivors.
The presence of lymph node metastases has a large impact on prognosis and
necessitates either intensification of radiotherapy or extended surgery.
Therefore, tailoring HNC treatment to individual patients requires an accurate
pretreatment assessment of the nodal status. The sentinel lymph node biopsy
(SNB) is current standard-of-care in oral cavity cancer and comprises
peritumoral 99mTc radioisotope injection followed by single photon emission
computed tomography (SPECT) for SN localization and surgical resection. The
procedure aims to identify the first echelon of draining lymph nodes, which are
resected and evaluated for metastatic disease. SNB is a reliable method for
staging the cN0 neck in oral cancer and identifying patients with small nodal
metastatic disease, but requires an invasive procedure including the use of
radioactive tracer.
Peritumoral injections of superparamagnetic iron oxide (SPIO) nanoparticles
hold promise as non-radioactive tracer to accurately detect sentinel lymph
nodes. After injection, the particles are drained via the lymphatic system and
become trapped in the SN(s). As a result of its paramagnetic properties, SPIO
generates a negative enhancement in T2*-weighted iron sensitive multi gradient
echo (MGRE) magnetic resonance imaging (MRI) sequences. Moreover, evaluation of
102 consecutive breast cancer patients who underwent SPIO-enhanced MRI for SLN
detection showed its capability in accurately staging the axillary SNs.
Assessment of lymph node status on a nodal basis showed a sensitivity,
specificity, NPV and PPV of 81.5, 90, 94.2, and 71%, respectively. A subsequent
study evaluating the pattern of SPIO uptake in 33 positive SLNs obtained from
30 breast cancer patients showed that in lymph nodes containing metastases of
>2 mm, the area of high signal intensity on SPIO-enhanced MRI correlated with
the size of metastases identified by pathology. These early results indicate
that SPIO-enhanced MRI is capable of minimally invasive SN assessment.
Study objective
To explore the feasibility of sentinel lymph node identification by SPIO
injection followed by MRI in head-and-neck cancer patients.
Study design
Single center feasibility study.
Study burden and risks
- Possible side-effects are predominantly hypersensitivity reactions following
subcutaneous SPIO administration. If injection appears to be painful, local
anesthetics will be used. Since we intend to use a very low dosage of SPIO we
expect a minimal risk of side-effects.
- Results of a recent trial in breast cancer from our colleagues from the
university of Twente show residual SPIO particles at the injection site after
an interval of approximately five years after administration in breast cancer
patients (unpublished data). Although considered harmless, these particles may
lead to (very small) artifacts on subsequent MRI-scans. The dose used in this
trial was substantially higher compared to the dose we intend to use. For this
reason we believe that this burden of residual SPIO is minimal.
- One MRI-scan which takes approximately 30 minutes and causes some discomfort.
- There is a low risk of unexpected findings.
Geert Grooteplein Zuid 32
Nijmegen 6525GA
NL
Geert Grooteplein Zuid 32
Nijmegen 6525GA
NL
Listed location countries
Age
Inclusion criteria
- Male or female aged >18 years.
- Patients with histopathologically proven cT1-2N0M0 squamous cell carcinoma of
the oral cavity.
- Patients planned to undergo routine sentinel node biopsy with
99mTc-radioisotope and SPECT-CT.
- Patient provided written informed consent.
Exclusion criteria
Patients who underwent previous surgery or radiotherapy to the neck.
Contra-indications to SPIO:
- prior allergic reaction to SPIO or any other iron preparation
- prior allergic reaction contributed to dextran or other polysaccharide, in
any preparation
- prior allergic reaction to contrast media of anytype
- hereditary hemochromatosis, thalassemia, sickle cell anemia
Patients unable to provide informed consent.
Design
Recruitment
Medical products/devices used
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In other registers
| Register | ID |
|---|---|
| CCMO | NL77078.091.21 |