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Intra-operative imaging of lymph node metastases in cervical cancer.


- candidate number6380
- NTR NumberNTR1981
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR31-aug-2009
- Secondary IDsBICG05UMCG-NIRF/NL26981.042.09 CCMO/UMCG
- Public TitleIntra-operative imaging of lymph node metastases in cervical cancer.
- Scientific TitleEvaluation of a clinical prototype near-infrared fluorescence (NIRF) imaging device for detection of lymph node (LN) metastases in cervical cancer: a technical feasibility study.
- ACRONYMN/A
- hypothesisImproved detection of tumor.
- Healt Condition(s) or Problem(s) studiedCervical cancer
- Inclusion criteria1. Female > 21 years of age;
2. Operable cervical cancer stage IAI, IBI or IIA.
- Exclusion criteria1. Renal, cardiac or pulmonary failure (ASA III-IV);
2. Pregnancy;
3. Iodine allergy or previous anaphylactic reactions;
4. Previous or present hyperthyreoidism.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-jul-2009
- planned closingdate
- Target number of participants10
- InterventionsPatients with cervical cancer undergoing surgery (radical hysterectomy with bilateral pelvic lymphadenectomy), will receive a peritumoural injection with Indocyanine Green (ICG) and patent blue after administration of full anaesthesia. During the operative procedure NIRF imaging for detection of the SLNs (i.e. ICG and patent blue accumulation) will take place.
- Primary outcomeIdentification of sentinel lymph nodes within the allocated procedure (usually 30 minutes) by detection of fluorescence.
- Secondary outcomeN/A
- TimepointsSurgery/intraoperative.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. G.M. Dam, van
- CONTACT for SCIENTIFIC QUERIESDr. G.M. Dam, van
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Groningen (UMCG)
- PublicationsN/A
- Brief summaryThis project consists on the realization followed by the clinical validation of a diagnostic procedure dedicated to sentinel lymph node (SLN) identification and localization in the case of cervical cancer. An intra-operative near-infrared fluorescence (NIRF) imaging camera and the use of a NIRF optical contrast agent will be evaluated for their feasibility to detect sentinel lymph nodes in patients with cervical cancer. The procedure which is currently the golden standard in cervical cancer is surgery combined with pelvic lymphadenectomy. The end-goal of the proposed intra-operative imaging procedure is to assess the feasibility of SLN detection with ICG and patent blue and the efficiency of the technique. Gynaecologic oncologist, surgeons and fundamental physics applied to medical imaging researchers are involved in this project.
- Main changes (audit trail)
- RECORD31-aug-2009 - 12-okt-2009


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