Added-Value of LM/SL Plus SPECT/CT in Gynecological Cancers
The purpose of this study is to assess the technical feasibility and the clinical added-value of SPECT/CT as a complement to LM/SL in patients with early stage of cervical cancer and vulvar cancer.
1. To compare the diagnostic accuracy of LM/SL + SPECT/CT versus LM/SL
- Rate of SLNs detected pre-operatively and intra-operatively
- Anatomic precision of SLNs detected pre-operatively (versus surgery)
2. To determine the predictive value of LM/SL + SPECT/CT for assessing regional lymph node status
- Rate of SLNs histologically involved versus non-SLNs
- Rate of tumor-free SLNs versus non-SLNS
3. To assess the safety of LM/SL + SPECT/CT
- Patients' tolerability
- Duration of operating time for SPECT-CT guided sentinel lymphadenectomy
- Complications rate
Allocation: Non-Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
SPECT/CT guided LM/SL
Lawson Health Research Institute
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT00972166
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
A network of nerve fibers originating in the upper four cervical spinal cord segments. The cervical plexus distributes cutaneous nerves to parts of the neck, shoulders, and back of the head, and motor fibers to muscles of the cervical spinal column, infrahyoid muscles, and the diaphragm.
Tomography, Emission-computed, Single-photon
A method of computed tomography that uses radionuclides which emit a single photon of a given energy. The camera is rotated 180 or 360 degrees around the patient to capture images at multiple positions along the arc. The computer is then used to reconstruct the transaxial, sagittal, and coronal images from the 3-dimensional distribution of radionuclides in the organ. The advantages of SPECT are that it can be used to observe biochemical and physiological processes as well as size and volume of the organ. The disadvantage is that, unlike positron-emission tomography where the positron-electron annihilation results in the emission of 2 photons at 180 degrees from each other, SPECT requires physical collimation to line up the photons, which results in the loss of many available photons and hence degrades the image.
Cervical Length Measurement
A parameter usually used in PRENATAL ULTRASONOGRAPHY to measure the length of the uterine neck (CERVIX UTERI). Cervical length or its shortening is used to identify and prevent early cervical opening and PRETERM BIRTH.
Head And Neck Neoplasms
Soft tissue tumors or cancer arising from the mucosal surfaces of the LIP; oral cavity; PHARYNX; LARYNX; and cervical esophagus. Other sites included are the NOSE and PARANASAL SINUSES; SALIVARY GLANDS; THYROID GLAND and PARATHYROID GLANDS; and MELANOMA and non-melanoma skin cancers of the head and neck. (from Holland et al., Cancer Medicine, 4th ed, p1651)
Uterine Cervical Neoplasms
Tumors or cancer of the UTERINE CERVIX.
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