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Updates Surgical Oncology : Theo Ruers group

Clinical Research: tracking of oral cavity carcinomas in head and neck surgery

Dr. M.B. Karakullukcu, Head and Neck Surgeon

Start date: April 2017
Number of patients: 50
Patients (age ≥ 18)  who are planned for surgery of tumors fixated to the maxilla or mandible and patients with tongue tumors (tumor size > T1).

The objective of this study is to evaluate the feasibility and clinical accuracy of an in‐house developed electromagnetic (EM) navigation system in determining adequate resection margins during surgery for malignant oral cavity tumors and specifically tongue tumors.

Clinical Research: targeted abdominal lymph node dissections randomized for surgical navigation

Prof. Th. J. M. Ruers, Oncological Surgeon

Start date: January 2017
Number of patients: 92
Patient group: Patients (age ≥ 18) planned for removal of at least one target lymph node during abdominal surgery.

Image-guided navigation surgery allows for full utilization of pre-operative imaging during surgery, and has the potential of reducing both irradical resections and morbidity. In this randomized study, patients which will undergo an abdominal lymph node dissection with our without image guidance in order to evaluate the actual technical and clinical benefit of navigation.

Clinical Research: Magnetic Marker Localization for Melanoma Surgery (MeMaLoc). A feasibility study

Prof. Th. J. M. Ruers, Oncological Surgeon


Start date: November 2016
Number of patients: 30
Patient group: Patients (age ≥ 18) with melanoma that are admitted to the hospital and are receiving either surgery for clinically occult locoregional and/or distant (sub)cutaneous or muscular metastases, or total lymph node dissection of the inguinal or axillar region.

To obtain proof-of-principle data that a novel intraoperative localization technology (MaMaLoc, magnetic marker localization) is feasible for:
1) Localizing clinically occult melanoma lesions.
2) Localizing lymph nodes.

Clinical Research: a prospective observational cohort for the clinical evaluation of innovative image guided surgical interventions in rectal cancer

Prof. Th. J. M. Ruers, Oncological Surgeon


Start date: October 2016
Number of patients: 250
Patient group: Patients (age ≥ 18) with rectal cancer receiving treatment in the Antoni van Leeuwenhoek hospital.

In this study, an infrastructure geared towards efficient, safe and comprehensive clinical evaluation of image guided surgical interventions for rectal cancer is build. This cohort will serve several purposes:
1) Patient pool from which candidates for the new interventions can be selected.
2) Control group against which outcomes of innovative surgical interventions can be compared.
3) Framework in which multiple studies can take place and can be compared.
4) Data collection for health technology assessment (HTA).
5) Surveillance of long term outcomes.

Clinical Research: real-time in vivo sensor tracking of rectal tumours during colorectal cancer surgery

Prof. Th. J. M. Ruers, Oncological Surgeon

Start date: September 2016
Number of patients: 21
Patient group: Patients (age ≥ 18) who are planned for low anterior resection (LAR) or abdominoperineal resection (APR)  with a tumour within 10 cm of the anal verge.

Image-guided navigation surgery allows for full utilization of pre-operative imaging during surgery, and has the potential of reducing both irradical resections and morbidity caused by damaged surrounding structures. This is a feasibility pilot study towards clinical implementation of a new navigation setup using tumour-tracking within the rectum during surgery.

Clinical Research: ImmunoModulation by the Combination of Ipilimumab and nivolumab neoadjuvant to Surgery In advanced Or recurrent Head and Neck Carcinoma (IMCISION), a phase-Ib/II trial

Dr. C.L. Zuur, Head and Neck Surgeon

Start date: August 2016
Number of patients: 32
Patient group: Patients (age ≥ 18) naïve for immunotherapy with histologically confirmed T3-4N0-3M0 HNSCC (in case of small T4 tumors, soft tissue infiltration depth of ≥ 1 cm) of the oral cavity, oropharynx, hypopharynx or supraglottic larynx, eligible for curative surgery as primary treatment or salvage surgery after failed (chemo)radiation.
 
In this study the feasibility and safety of checkpoint blockade neoadjuvant to standard of care (SOC) in advanced HNSCC is evaluated. In addition, with this research protocol the potential impact of intratumoral hypoxia on tumor infiltrating lymphocyte (TIL) abundance, differentiation and effector function, and the potentially divergent effects of T cell checkpoint blockade in areas of hypoxia and normoxia is studied. Within the study protocol the use of na image guided biopsy procedure is evaluated.

Clinical Research: tracking of liver metastases during surgery

Prof. Th. J. M. Ruers, Oncological Surgeon

Start date: June 2016
Number of patients: 53
Patient group: Patients (age ≥ 18) with superficial  liver metastasis who are scheduled for open liver surgery.

Image-guided navigation surgery allows for full utilization of pre-operative imaging during surgery, and has the potential of reducing both irradical resections and morbidity. This is  a feasibility study towards clinical implementation of perioperative tumor tracking during open liver surgery.

Clinical Research: In vivo identification of rectum and colon carcinoma during surgery using optical spectroscopy techniques.

Prof. Th. J. M. Ruers, Oncological Surgeon

Start date: June 2014
Number of patients: 47
Patient group: Patients (age ≥ 18) planned for elective colorectal surgery for either primary or recurrent colorectal cancer by an open or laparoscopic approach, and patients planned for a HIPEC procedure for colorectal cancer.

The primary objective of this pilot study is to calculate the sensitivity and specificity for discriminating tumour and benign tissues in vivo in colorectal cancer patients based on optical spectroscopy measurements. In additon the  the spectral differences between in vivo and ex vivo measurements and the difference in the biological parameters (i.e. blood, water and fat content and blood oxygenation) that are extracted from the spectral information are determined.

Clinical Research: image-guided navigation during abdominal surgery

Prof. Th. J. M. Ruers, Oncological Surgeon


Start date: October 2013
Number of patients: 75
Patient group: Patients (age ≥ 18) who are scheduled for abdominal surgery by laparotomy.

The primary goal of this study is to evaluate the accuracy of an in-house developed electromagnetic navigation system during abdominal surgery. In addition, possible improvements of the navigation hardware and software will be recorded and the handling during surgery will be evaluated.

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