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Added-value of SPECT/CT to lymphatic mapping and sentinel lymphadenectomy in gynaecological cancers.

ABSTRACT: Lymphatic mapping and sentinel lymphadenectomy (LM/SL) have been successfully used in pre-treatment nodal staging of gynaecological cancers. We hypothesised the added-value of LM/SL plus SPECT/CT in patients with early stage of cervical cancer and vulvar cancer. A prospective, single-center, diagnostic, open label, active control, non-randomized clinical trial has been conducted in 7 patients with FIGO IA-IB1 cervical cancer and 7 patients with FIGO stage I-II-IIIcN0 vulvar cancer. All patients underwent LM/SL plus SPECT/low-dose CT and complete lymph node dissection (CLND) according to the standard of care. In case of negative hematoxylin-eosin staining, serial sections of the SLNs were analysed by immunohistochemistry and high molecular weight cytokeratin. Primary outcome measures were the detection rate, the sensitivity (SV), the negative predictive value (NPV), the diagnostic accuracy (DA) for anatomic localisation of SLNs, and the impact on management of SPECT/CT guided LM/SL versus CLND. The secondary outcome measure was the patient tolerability and operating time of LM/SL guided SPECT/CT versus CLND. http://clinicaltrials.gov/show/NCT00773071 All 14 patients were enrolled into the 1-day research protocol with dual-tracer LM/SL and SPECT/CT. Additional SLNs were detected on SPECT/CT compared to conventional planar imaging. Hot and cold > 1cm SLNs were detected on SPECT/CT. Detection rate, SV, NPV, DA were 100% in both groups; false negative rate was 0%. Rate of SLN metastases was 28.5% in cervical cancer and 42.9% in vulvar cancer. Impact on treatment was 28.5% and 14.3% in cervical cancer and vulvar cancer patients, respectively. SPECT/CT was well tolerated by all patients and operating time for LM/SL was within 30 min. No adverse events were reported with a time frame of 1-to-3 years. In early stage of gynaecological cancers, SPECT/low-dose CT is technically feasible and of clinical added-value for LM/SL.

SUBMITTER: Belhocine TZ

PROVIDER: S-EPMC3601478 | biostudies-literature | 2013

REPOSITORIES: biostudies-literature

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Added-value of SPECT/CT to lymphatic mapping and sentinel lymphadenectomy in gynaecological cancers.

Belhocine Tarik Z TZ Prefontaine Michel M Lanvin Dominique D Bertrand Monique M Rachinsky Irina I Ettler Helen H Zabel Pamela P Stitt Larry W LW Sugimoto Akira A Urbain Jean-Luc JL

American journal of nuclear medicine and molecular imaging 20130308 2

Lymphatic mapping and sentinel lymphadenectomy (LM/SL) have been successfully used in pre-treatment nodal staging of gynaecological cancers. We hypothesised the added-value of LM/SL plus SPECT/CT in patients with early stage of cervical cancer and vulvar cancer. A prospective, single-center, diagnostic, open label, active control, non-randomized clinical trial has been conducted in 7 patients with FIGO IA-IB1 cervical cancer and 7 patients with FIGO stage I-II-IIIcN0 vulvar cancer. All patients ...[more]

PMID: 23526734

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Project description:BACKGROUND:The majority of patients with head and neck squamous cell carcinoma (HNSCC) receive bilateral elective nodal irradiation (ENI), in order to reduce the risk of regional failure. Bilateral ENI, as compared to unilateral ENI, is associated with higher incidence of acute and late radiation-induced toxicity with subsequent deterioration of quality of life. Increasing evidence that the incidence of contralateral regional failure (cRF) in lateralized HNSCC is very low (< 10%) suggests that it can be justified to treat selected patients unilaterally. This trial aims to minimize the proportion of patients that undergo bilateral ENI, by using lymph drainage mapping by SPECT/CT to select patients with a minimal risk of contralateral nodal failure for unilateral elective nodal irradiation. METHODS:In this one-armed, single-center prospective trial, patients with primary T1-4 N0-2b HNSCC of the oral cavity, oropharynx, larynx (except T1 glottic) or hypopharynx, not extending beyond the midline and planned for primary (chemo) radiotherapy, are eligible. After 99mTc-nanocolloid tracer injection in and around the tumor, lymphatic drainage is visualized using SPECT/CT. In case of contralateral lymph drainage, a contralateral sentinel node procedure is performed on the same day. Patients without contralateral lymph drainage, and patients with contralateral drainage but without pathologic involvement of any removed contralateral sentinel nodes, receive unilateral ENI. Only when tumor cells are found in a contralateral sentinel node the patient will be treated with bilateral ENI. The primary endpoint is cumulative incidence of cRF at 1 and 2 years after treatment. Secondary endpoints are radiation-related toxicity and quality of life. The removed lymph nodes will be studied to determine the prevalence of occult metastatic disease in contralateral sentinel nodes. DISCUSSION:This single-center prospective trial aims to reduce the incidence and duration of radiation-related toxicities and improve quality of life of HNSCC patients, by using lymph drainage mapping by SPECT/CT to select patients with a minimal risk of contralateral nodal failure for unilateral elective nodal irradiation. TRIAL REGISTRATION:ClinicalTrials.gov Identifier: NCT03968679, date of registration: May 30, 2019.

Project description:ObjectivesTo determine the diagnostic ability of cervical mucosa radiomics signature of sagittal T2WI and T1 contrast-enhanced (CE) imaging in detecting early-stage cervical cancers with negative MRI.MethodsPreoperative images of postoperative pathology confirmed early-stage cervical cancer patients and normal cervix patients admitted to our hospital between January 2013 and December 2020 were retrospectively reviewed. Patients with cancer signals on T2WI, T1CE and DWI were deleted. Regions of interests (ROIs) were delineated on cervical mucosa (from cervical canal to cervical dome) with 5 mm width on sagittal T2WI and T1CE. The maximum-relevance and minimumredundancy (mRMR) and least absolute shrinkage and selection operator (LASSO) methods were used for the calculation of radiomics signature scores. Diagnostic performance was assessed and compared between radiomics prediction models (model 1: T1CE; model 2: T2WI; model 3: model one combined with model 2). Differential diagnostic ability of radiomics signature in detecting lymphatic vascular space invasion (LVSI) was further explored.ResultsDiagnostic performance of model three was higher than model 1 and model 2 both in primary (model 3 0.874, model 1 0.857, model 2 0.816) and validation (model 3 0.853, model 1 0.847, model 2 0.634) cohorts. Model 3 showed statistical diagnostic difference compared with model 2 (primary p = 0.008, validation p = 0.000). However, the diagnostic improvement ability of model 3 showed no statistical difference compared with model 1 (primary p = 0.351, validation p = 0.739). Diagnostic efficiency of model 3 in detecting LVSI was not apparent (AUC 0.64).ConclusionsRadiomics analysis of cervical mucosa combining T1CE and T2WI is promising for predicting MRI invisible early-stage cervical cancers, however further ability in detecting LVSI was not apparent.Advances in knowledgeConventional MRI was originally defined as meaningless in very early-stage cervical cancers. However, whether MRI radiomics analysis of cervical mucosa can detecting tiny changes of invisible early stage cervical cancers has not been researched yet.

Dataset Information

Added-value of SPECT/CT to lymphatic mapping and sentinel lymphadenectomy in gynaecological cancers.

Publications

Added-value of SPECT/CT to lymphatic mapping and sentinel lymphadenectomy in gynaecological cancers.

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