The primary objective of this study is to evaluate the feasibility and diagnostic accuracy of pre-operative MRI scanning using SPIO compared to lymphoscintigraphy (LS) and single-photon emission computed tomography/computed tomography (SPECT/CT)…
ID
Source
Brief title
Condition
- Skin neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The diagnostic accuracy of SPIO/MRI and LS+SPECT/CT and 99mTc to identify SLN
will be expressed as sensitivity and specificity, and positive and negative
predictive values, including their 95% exact binomial confidence intervals. MRI
image analyses will be performed by two independent professionals.
Secondary outcome
The diagnostic accuracy of SPIO/magnetometer and 99mTc and Gamma probe will be
expressed as sensitivity and specificity, and positive and negative predictive
values, including their 95% exact binomial confidence intervals.
Comparison between 99mTc injection + LS + SPECT/CT time vs SPIO injection + MRI
Number of days between preoperative MRI and SLNB.
Moreover, the MRI workflow protocol will be validated and potentially
optimized.
Background summary
Sentinel lymph node biopsy (SLNB) is crucial in the management of malignant
melanoma treatment and is currently performed by pre-operatively inject a
colloid nanomaterial labeled with Technetium (99mTc) as radioactive tracer.
Intra-operatively, Patent Blue (PB) will be injected to improve the
visualization of the lymphatic tract. However, current pre-operative SLN
mapping technique, is associated with disadvantages as radiation exposure for
both patients and health care staff and logistic challenges, because of time
constraints due to short half-live time of 99mTc.
Superparamagnetic iron oxide (SPIO) is a novel, non-radioactive technique using
a magnetic tracer (Magtrace® (Endomagnetics Ltd.)) to identify SNLs. Several
studies showed that SPIO is non-inferior to dual tracing with 99mTc and PB in
breast cancer patients. SPIO is expected to be non-inferior to dual tracing
with 99mTc and PB in melanoma patients. However, further research is needed to
demonstrate the use of SPIO in pre-operative MRI scanning.
Study objective
The primary objective of this study is to evaluate the feasibility and
diagnostic accuracy of pre-operative MRI scanning using SPIO compared to
lymphoscintigraphy (LS) and single-photon emission computed tomography/computed
tomography (SPECT/CT) using 99mTc for identifying SLN status in melanoma
patients. A secondary objective is to assess the feasibility and diagnostic
accuracy of SPIO/magnetometer (Sentimag®, Endomagnetics Ltd.) in comparison
with gold standard (99mTc) in SLN procedures in melanoma patients.
Study design
A prospective single-arm feasibility study will take place at the department of
Surgical oncology of Zuyderland Medical Center Sittard, the Netherlands. All
melanoma patients with an indication for SLN procedure will undergo lymphatic
mapping with 99m Tc and SPIO.
Study burden and risks
The aim of the study is to evaluate the feasibility and diagnostic accuracy of
SPIO/MRI in SNL procedures in melanoma patients. Magtrace® is formerly approved
and used in breast cancer patients. Except one extra hospital visit, no burden
and risks are associated with participation.
Henri Dunantstraat 5
Heerlen 6419 PC
NL
Henri Dunantstraat 5
Heerlen 6419 PC
NL
Listed location countries
Age
Inclusion criteria
Patients >=18 years of age at the time of consent;
Histological confirmed melanoma (patient must have primary cutaneous melanoma
with
Breslow thickness >= 0.8-2.0mm with or without ulceration or <0.8mm with
ulceration (pT1b - pT2b, AJCC 8th edition));
Indication for wide local excision (margin 1 cm) and SLN procedure;
Patients should be willing and able to provide informed consent.
Exclusion criteria
Intolerance/hypersensitivity to 99mTc-nanocolloid, PB, iron or dextran
compounds;
Iron overload disease;
Pregnant or breast-feeding women;
Previous surrounded lymph node surgery;
Patients with head and neck melanomas;
Standard MRI exclusion criteria;
- Implantable (electrical) devices (e.g. pacemaker, cochlear implants,
neurostimulator);
- Any other metal implants;
- Claustrophobia;
- MR-incompatible prosthetic heart valves;
Patients who are unable or refuse to provide informed consent.
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 | NL78185.096.21 |