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Sponsor study identifier
Secondary identifiers
REGISTRY · UWO Research Ethics Board number
interventional
15
1 country
1
Study Start
April 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2012
Actual (reported)Study Completion
February 2012
Actual (reported)Nodal staging is a key-step in pre-treatment assessment of gynecological cancers. In recent years, lymphatic mapping and sentinel lymphadenectomy (LM/SL) as a minimally invasive pelvic lymph nodes staging has been successfully evaluated in women with early stage of vulvar cancer, cervical cancer, and endometrial cancer. Such a technique may offer several valuable advantages: a) it is readily applicable in clinical routine using a safe, inexpensive, and reproducible protocol; b) it may help to avoid the cost and the morbidity of unnecessary lymphadenectomy in the majority of cases with uninvolved sentinel lymph nodes; c) it has the potential to guide the surgeon to nodal regions that are not routinely dissected (i.e. pre-sacral, para-aortic nodes) and to identify micro-metastases that would have been ignored otherwise; d) it also offers the basis for sophisticated pathological analysis to detect sub-microscopic nodal metastases using either immunohistochemical or molecular biological techniques. So far, within the abdomen and the pelvis, the LM/SL technique alone is often blinded to the accurate localization of SLNs. The integration of computed tomography (CT) to single photon emission computed tomography (SPECT) devices in a single gantry (SPECT/CT) has allowed a significant gain in terms of diagnostic accuracy and anatomic precision; clinical examples include malignant melanoma, head and neck cancer, breast cancer, and bladder cancer. In a seminal series of 26 patients with cervical cancer (Zhang et al., 2006), SPECT/CT was recently found superior to conventional planar imaging for detection of SLN and accurate localization. A more recent study (Kushner al., 2007) has also highlighted the technical feasibility and the clinical added-value of a low-dose SPECT/CT in a series of 20 patients with early stage cervical cancer (IA2-IIA) who underwent LM/SL. In the light of the encouraging data from literature and our own preliminary clinical experience, we hypothesized that the use of LM/SL plus SPECT/CT may be of clinical interest in patients with gynecological cancers.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2012
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2008
Date type not reportedThis date has not been verified as actual or estimated.
July 25, 2008
Actual (reported)October 16, 2008
Actual (reported)February 2012
Actual (reported)February 2012
Actual (reported)Sensitivity, predictive value, anatomic localization, and impact on management of SPECT/CT guided LM/SL versus CLND
6 months -1 year
Patient tolerability and operating time for SPECT/CT guided LM/SL versus CLND
6 months - 1 year
Single photon emission computed tomography/computed tomography (SPECT/CT) guided lymphatic mapping and sentinel lymphadenectomy (LM/SL) vs. complete lymph node dissection (CLND) All cervical cancer and vulvar cancer patients will undergo CLND according to the standard of care in gynecologic cancers as recommended by the International Federation of Gynecology and Obstetrics (FIGO). Patients with FIGO IA2 and IB1 cervical cancers will be scheduled for radical hysterectomy and pelvic lymph node dissection. Patients with FIGO IB and II vulvar cancers and those of patients with FIGO III with clinically negative regional lymph nodes will be scheduled for vulvectomy and inguinal lymph node dissection.
Pre-operatively, SLNs will be detected by low-dose SPECT/CT (99mTc-cystein rhenium colloids, 1cc/1mCi). Intra-operatively, a blue-dye (Patent Blue, 2cc) and a gamma-probe guidance will be used to detect the SLN nodes. All blue-stained and/or hot lymph nodes with a radioactivity greater than 10% of the hottest node will be considered as SLNs. Serial sections of SLNs will be analyzed by H-E staining. In cases of negative H-E, the SLNs will be further analyzed by immunochemistry (CKAE1/CKAE3, and high molecular weight Cytokeratin 34BE12). Non-SLNs will be analyzed as usual in routine by H-E.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
375, South Street Hospital - Dpt. of Nuclear Medicine
London, Ontario, N6A4G5, Canada
Kushner DM, Connor JP, Wilson MA, Hafez GR, Chappell RJ, Stewart SL, Hartenbach EM. Laparoscopic sentinel lymph node mapping for cervix cancer--a detailed evaluation and time analysis. Gynecol Oncol. 2007 Sep;106(3):507-12. doi: 10.1016/j.ygyno.2007.04.031. Epub 2007 Jun 8.
Zhang WJ, Zheng R, Wu LY, Li XG, Li B, Chen SZ. [Clinical application of sentinel lymph node detection to early stage cervical cancer]. Ai Zheng. 2006 Feb;25(2):224-8. Chinese.
Irina Rachinsky, MD, MSc
The University of Western Ontario - Nuclear Medicine
Jean-Luc Urbain, MD, PhD
The University of Western Ontario - Nuclear Medicine
Monique Bertrand, MD, PhD
The University of Western ontario - Gynaecology
Helen Ettler, MD
The University of Western Ontario -Pathology
15 participants (actual enrollment reported by the registry).
First Submitted
July 25, 2008
First Posted
October 16, 2008
Study Start
April 2008
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Belhocine T, Kridelka F, Thille A, De Barsy C, Foidart-Willems J, Hustinx R, Rigo P. Staging of primary cervical cancers: the role of nuclear medicine. Crit Rev Oncol Hematol. 2003 Jun;46(3):275-84. doi: 10.1016/s1040-8428(03)00027-1.
Van der Zee AG, Oonk MH, De Hullu JA, Ansink AC, Vergote I, Verheijen RH, Maggioni A, Gaarenstroom KN, Baldwin PJ, Van Dorst EB, Van der Velden J, Hermans RH, van der Putten H, Drouin P, Schneider A, Sluiter WJ. Sentinel node dissection is safe in the treatment of early-stage vulvar cancer. J Clin Oncol. 2008 Feb 20;26(6):884-9. doi: 10.1200/JCO.2007.14.0566.
Levenback CF. How safe is sentinel lymph node biopsy in patients with vulvar cancer? J Clin Oncol. 2008 Feb 20;26(6):828-9. doi: 10.1200/JCO.2007.14.7124. No abstract available.
Levenback CF. Status of sentinel lymph nodes in cervical cancer. Gynecol Oncol. 2007 Oct;107(1 Suppl 1):S18-9. doi: 10.1016/j.ygyno.2007.07.039. Epub 2007 Aug 29. No abstract available.
van de Lande J, Torrenga B, Raijmakers PG, Hoekstra OS, van Baal MW, Brolmann HA, Verheijen RH. Sentinel lymph node detection in early stage uterine cervix carcinoma: a systematic review. Gynecol Oncol. 2007 Sep;106(3):604-13. doi: 10.1016/j.ygyno.2007.05.010. Epub 2007 Jul 12.
Benedet JL, Bender H, Jones H 3rd, Ngan HY, Pecorelli S. FIGO staging classifications and clinical practice guidelines in the management of gynecologic cancers. FIGO Committee on Gynecologic Oncology. Int J Gynaecol Obstet. 2000 Aug;70(2):209-62. No abstract available.
Martinez A, Zerdoud S, Mery E, Bouissou E, Ferron G, Querleu D. Hybrid imaging by SPECT/CT for sentinel lymph node detection in patients with cancer of the uterine cervix. Gynecol Oncol. 2010 Dec;119(3):431-5. doi: 10.1016/j.ygyno.2010.08.001. Epub 2010 Sep 6.
Pandit-Taskar N, Gemignani ML, Lyall A, Larson SM, Barakat RR, Abu Rustum NR. Single photon emission computed tomography SPECT-CT improves sentinel node detection and localization in cervical and uterine malignancy. Gynecol Oncol. 2010 Apr;117(1):59-64. doi: 10.1016/j.ygyno.2009.12.021. Epub 2010 Feb 1.
Diaz-Feijoo B, Perez-Benavente MA, Cabrera-Diaz S, Gil-Moreno A, Roca I, Franco-Camps S, Fernandez MS, Garcia-Jimenez A, Xercavins J, Martinez-Palones JM. Change in clinical management of sentinel lymph node location in early stage cervical cancer: the role of SPECT/CT. Gynecol Oncol. 2011 Mar;120(3):353-7. doi: 10.1016/j.ygyno.2010.12.336. Epub 2011 Jan 6.
Freudenberg LS, Gortz E, Hagen C, Harms E, Koska WW, Marlowe RJ, Shadouh S, Stock C. Lymphatic mapping using SPECT/CT in vulvar carcinoma. Clin Nucl Med. 2010 Dec;35(12):950-2. doi: 10.1097/RLU.0b013e3181f9de96. No abstract available.
Kobayashi K, Ramirez PT, Kim EE, Levenback CF, Rohren EM, Frumovitz M, Mar MV, Gayed IW. Sentinel node mapping in vulvovaginal melanoma using SPECT/CT lymphoscintigraphy. Clin Nucl Med. 2009 Dec;34(12):859-61. doi: 10.1097/RLU.0b013e3181becdaf.
Belhocine TZ, Prefontaine M, Lanvin D, Bertrand M, Rachinsky I, Ettler H, Zabel P, Stitt LW, Sugimoto A, Urbain JL. Added-value of SPECT/CT to lymphatic mapping and sentinel lymphadenectomy in gynaecological cancers. Am J Nucl Med Mol Imaging. 2013;3(2):182-93. Epub 2013 Mar 8.
Primary Completion
February 2012
Actual (reported)Study Completion
February 2012
Actual (reported)Last Updated
June 8, 2012
Record last verified: 2012-06
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