Neoplasms

All Conditions

Abdominal Neoplasms

Central Nervous System Depressants

All Drugs and Chemicals

Anesthetics

Patients are 18 years old or older. Patients are scheduled for tumor surgery in the abdominal/pelvic area and navigation surgery with a scheduled Cone Beam CT-scan in the operating room. Patients provide written 'informed consent'. The to be administered intervention is a percutaneous tracked ultrasound measurement of the patient's pelvic bone on the operating room after anesthesia.

Participation in the study will not involve additional visits to the hospital or additional CT scans for the included patients. For this experiment, 2D ultrasound images are obtained using an ultrasound transducer linked to the electromagnetic navigation system, which is already in place for the navigation at the operating room. After anesthesia and in parallel to the final preparations of the patient, two percutaneous ultrasound measurements of the pelvic bone are performed and recorded. The first measurements are performed in Trendelenburg patient position and the second measurements in supine patient position. When preparations are finished, normal workflow is continued, including the standard Cone Beam CT acquisition required for the navigation and sterile draping of the patient.

The acquired ultrasound scans will be analyzed post-operatively and offline. This measurement has no impact on the (navigated) surgical procedure itself.

Tracked ultrasound measurement

Theo Ruers, prof. dr.

The goal of this observational pilot study is to evaluate the feasibility and accuracy of tracked ultrasound registration on patients undergoing abdominal cancer navigation surgery. The main research question is: Could tracked ultrasound be applied as an alternative to standard CBCT scanning in surgical navigation? Participants will undergo tracked ultrasound measurements of the pelvic bone on the operating room after patient anesthesia and before surgical incision.

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. Currently, registration is done by Cone-Beam CT (CBCT) scanning on the operating room (OR) prior to navigation surgery. However, standard CBCT scanning has several limitations, mainly limited availability on the hybrid OR and radiation exposure. Furthermore, standard CBCT scanning can only be performed in horizontal patient position, while the patient position mostly differs during surgery, such as the Trendelenburg position. The use of tracked ultrasound instead of standard CBCT could overcome these limitations, which might lead to an increased navigation accuracy and improved surgical outcomes. Therefore, the goal of this research is to evaluate the feasibility and accuracy of tracked ultrasound registration on patients undergoing abdominal cancer navigation surgery. The main research question is: Could tracked ultrasound be applied as an alternative to standard CBCT scanning in surgical navigation?

Tracked Ultrasound for Patient Registration in Surgical Navigation During Abdominal Cancer Surgery

To evaluate the accuracy of tracked ultrasound registration on patients undergoing abdominal cancer navigation surgery. This will be assessed using the target registration error in mm, where a lower error means a better outcome.

What is the influence of patient position alteration on the surgical navigation accuracy for standard Cone Beam CT and tracked ultrasound registration methods? This will be assessed using the target registration discrepancy in mm.

The time duration of ultrasound measurements will be recorded and compared with the conventional Cone Beam CT method. A faster ultrasound measurement time means a better outcome.

The Netherlands Cancer Institute

Blood and Lymph Conditions

Nervous System Diseases

Rare Diseases

Sarcoma

Leukemia

Brain Neoplasms

Neoplasms by Histologic Type

Neoplasms, Connective and Soft Tissue

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Soft Tissue Sarcoma

Brigitte C Widemann, M.D.

Background:

- The Children s Oncology Group has established a research network, the Childhood Cancer Research Network (CCRN), to collect information about children with cancer and other conditions that are benign but involve abnormal cell growth in order to help doctors and scientists better understand childhood cancer. The CCRN's goal is to collect clinical information about every child diagnosed with cancer and similar conditions in the United States and Canada, to allow researchers to study patterns, characteristics, and causes of childhood cancer. The information can also help researchers study the causes of childhood cancer. To expand the CCRN, parents of children who have been diagnosed with cancer will be asked to provide information about themselves and their child for research purposes.

Objectives:

* To obtain informed consent from parents (and the child, when appropriate) of infants, children, adolescents, and young adults newly diagnosed with cancer to enter their names and certain information concerning their child into the Childhood Cancer Research Network.
* To obtain informed consent from parents (and the child, when appropriate) of infants, children, adolescents, and young adults newly diagnosed with cancer for permission to be contacted in the future to consider participating in non-therapeutic and prevention research studies involving the parents and/or the child.

Eligibility:

- Parents of children who have been seen at or treated by a hospital that is a member of the Children s Oncology Group.

Design:

* Parents will provide permission to have personal information sent from their child s hospital to the CCRN, including the child and parents' names; child's gender, birth date, race, and ethnicity; information about the disease; and the treating institution.
* Parents will also give permission for CCRN to contact the diagnostic laboratory to obtain specific information about the tumor or cancer cells.
* Parents will be asked if they are willing to be contacted in the future to consider participating in CCRN research studies, and will provide contact information (name, home address, and telephone number) to be entered in the CCRN.
* Parents or patients who change their minds about having information available in the CCRN can ask the treatment institution to restrict access to the identifying information. Parents or patients who refuse to have information included in the CCRN or be contacted in the future will still be able to enter clinical cancer research studies.

Background:

* Institutional membership in the Children s Oncology Group (COG) requires registration of all pediatric cancer patients seen at their site. This registration process includes all patients.
* In order to maximize the resource that a network would provide, it is necessary to have identifying information on a large proportion of the cases included within the network. Moreover, the resource would be further enhanced if informed consent from parents/patients was obtained to allow future contact regarding possible participation in non-therapeutic and prevention research.

Objectives:

* To obtain informed consent from parents of infants, children, adolescents, and young adults newly diagnosed with cancer (and their child when appropriate) to enter their names and certain information concerning their child into the Childhood Cancer Research Network and/or for permission to be contacted in the future to consider participating in future studies.
* For children under the age of majority at the time of parental consent: Once the child reaches the age of majority, to obtain informed consent from that child to allow her/his name and other identifying information to continue to be available to the Childhood Cancer Research Network and/or to be possibly contacted in the future to consider participating in other studies.

Eligibility:

* Pre-CCRN Entry
* All new patients seen in COG member institutions with any of the following diagnoses are eligible:

  -- All cancer cases with an ICD-O histologic behavior code of two 2 (carcinoma in situ) or three 3 (malignant).
* -All lesions of the central nervous system regardless of behavior, i.e., benign, borderline or malignant.

  * The benign/borderline conditions which will be reportable by agreement shall include: Mesoblastic nephroma, all teratomas, regardless of locations, Theca cell - granulosa cell tumor, lymphoproliferative disease, ganglioneuroma, myeloproliferative disease, Langerhan s Cell histiocytosis

Design:

If consent to enter the patient in ACCRN07 is obtained:

1. Using the patient s COG ID, the CCRN consent will be added to their record and the patient will be considered registered with COG.
2. Depending on the response on the consent form, the record will be flagged for a yes or no to possible contact for future studies in the CCRN.

If consent is not obtained to enter the patient in ACCRN07

1. For those parents/patients who refuse the CCRN consent, they will still be able to be enrolled on any COG clinical trial (therapeutic and non- therapeutic) for which the patient is eligible. The unique COG ID will be used to identify the patient.
2. The information collected as part of the study entry procedures will not be available to the CCRN. The record will be flagged as refusing participation in the CCRN.
3. If consent is later obtained for enrollment in the CCRN, the patient must be entered in ACCRN07 using the patient s unique COG ID.

Enrollment on the Childhood Cancer Research Network (CCRN) of the Children s Oncology Group

Protocol for the Enrollment on the Official COG Registry, The Childhood Cancer Research Network (CCRN) Children s Oncology Group

National Cancer Institute (NCI)

This is a single-center observational feasibility study to develop an automatic segmentation and registration algorithm based on ultrasound imaging of the pelvic arteries. The duration of this study will be approximately 1 year. Patients scheduled for a laparotomy at the NKI are eligible for inclusion. Patients are informed about the study before the planned surgery and, after being provided with the necessary information regarding participation in the study, will be asked for informed consent. The ultrasound acquisitions for this study will be performed intra-operatively with CE marked equipment for intra-operative ultrasound. There is no impact on the standard surgical procedure or decision making of the surgery. After surgery, no further participation or cooperation of the patient is required.

A patient-specific 3D model will be created using an available pre-operative CT scan. Anatomical target points are selected on this virtual model before the start of the surgery. Prior to surgery, a patient-reference electromagnetic (EM) sensor will be placed between the patient and the matrass on the operating table to account for patient movement during acquisition. Intra-operatively, an initial point registration of the 3D model with the electromagnetic tracking system (EMTS) will be performed based on ultrasound (US) imaging of the arterial bifurcations by the surgeon. Then, the surgeon will acquire multiple US sweeps of the pelvic arteries (abdominal aorta and left and right iliac arteries). For validation purposes, the pre-operatively defined anatomical target points will be visualized on US imaging and by pinpointing the EM tracked pointer. All tracking and US data will be recorded and stored for post-operative analysis.

Intra-operative ultrasound measurement

Marijn Hiep, MSc

Theo Ruers, Prof. Dr.

Wout Heerink, Dr.

Harald Groen, Dr.

In this study we aim to develop an automatic pelvic artery segmentation algorithm, which is required for future clinical implementation of US registration for surgical navigation. Various registration methods will be evaluated with the data of this study to obtain most optimal results. If automatic segmentation and registration is successful, the final accuracy of the developed US registration method for tumor tracking should be evaluated in future studies in patients eligible for surgical navigation. Eventually, we aim to replace the CBCT-scan with an automatic tracked US registration pipeline for a more efficient and accurate registration procedure, which could improve the applicability and accuracy of surgical navigation and patient outcomes.

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. To use navigation, a registration procedure is required to correlate pre-operative imaging with the patient's position on the operating room (OR). Currently, registration is done by Cone-Beam CT (CBCT) scanning on the OR prior to navigation surgery. However, the main limitation of the CBCT method is that it cannot compensate for per-operative changes such as bed rotation, retractor placement and tissue displacement due to the surgery. Alternatively, by using intra-operative tracked ultrasound and vessel-based patient registration, changing conditions during surgery can better be dealt with. This improved patient registration method could lead to an increased navigation accuracy and improved clinical usability and outcomes.

The main difference between CBCT and proposed ultrasound registration is that CBCT is based on bones, while the ultrasound is based on vessels. Bones can be very easily imaged on the CBCT and therefore used for bone-bone registration with pre-operative CT-scans. However, vessels are more difficult to acquire, especially with ultrasound, and an automatic registration process with pre-operative imaging is needed for efficient clinical usability. For this, the vessels need to be extracted from the tracked ultrasound images to create a 3D representation that can be registered. Therefore, an algorithm needs to be developed that can automatically segment the pelvic vessels from ultrasound images.

One group to evaluate the feasibility and accuracy of the proposed methods.

Vessel-based Ultrasound Registration

Intra-operative Pelvic Vessel Acquisition, Towards Ultrasound Registration for Surgical Navigation

An automatic segmentation algorithm for real-time intra-operative pelvic vessel segmentation from tracked US images will be developed. The accuracy of this network will be evaluated using the Dice similarity coefficient, ranging from 0 to 1 where a higher score means a better outcome.

To evaluate the accuracy of different patient registration methods of intra-operative US imaging with pre-operative CT imaging, such as 3D model or centerline registration.

Evaluation of the intraoperative usability of the tracked US device and visualization of pelvic vessels by the surgeons will be evaluated using the system usability scale (SUS). This scale ranges from 0-100 where a higher score means a better outcome.

Musculoskeletal Diseases

Soft Tissue Neoplasms

Bone Neoplasms

Bone Diseases

Registration according to approved data sets

Registration

Bruno Fuchs, MD PhD

Registration of all sarcoma patients treated at a specialized sarcoma center in Switzerland.

SCIENTIFIC BACKGROUND OF STUDY, EXPECTED OUTCOME, AND RELEVANCE Sarcomas represent malignant bone and soft tissue tumours. Overall, these are very rare tumours representing less than 1% of all cancers (besides carcinomas and haematological cancers). Furthermore, with the advent of molecular knowledge, more than 100 subtypes of sarcomas can be distinguished and many of them share a distinct biological behaviour opening the possibility of targeted therapy. The management of patients with sarcomas is extremely complex and highly multidisciplinary, involving the pathologist, the orthopaedic oncologist, a paediatric and medical oncologist, the radiation oncologist, the reconstructive as well as visceral and chest surgeon. Surgery remains the mainstay of treatment, but almost always in combination with either radiotherapy or chemotherapy, or novel targeted therapy. The key of successful therapy (and consequent successful outcome for the patient) remains the orchestrated team approach among these disciplines where the therapeutic strategy is interdisciplinary determined at the sarcoma board. Unfortunately, all too often and still nowadays, patients also in Switzerland are not treated within such a network. E.g., too many surgeons still believe that they are capable to remove a soft tissue lump (which technically is true), just to send the patient off after surgery to the medical oncologist, and never see the patient again. All too often this may result for example in an unnecessary amputation, a devastating consequence for the patient. A surgeon needs to be aware of the interpretation of the pathologic specimen, the possibilities of adjuvant treatment, and most importantly, the biology of each subtype of sarcoma, before embarking on surgery. Because of all the reasons listed above, it is very reasonable to centralize the treatment of sarcoma patients to improve the treatment and outcome for sarcoma patients in Switzerland, as is foreseen by the current initiative of HSM by the GDK. It is very important to state that such uncoordinated treatment of sarcoma patients with the potential deleterious consequences is an international phenomenon. Many groups have independently established that the lack of interdisciplinarity leads to worse patient outcome and survival. Many reasons account for this: rarity of disease, lack of knowledge, lack of awareness, and all too often also pride and prestige. The only way out is to bring treating physicians together and to make the institutions aware that applying simple management strategies -such as coordinated treatment- does improve the outcome of sarcoma patients, which has been proven in many countries already. Nowadays in Switzerland, there are only very few groups/institutions who deal exclusively with sarcoma patients. Consequently, the therapeutic approach and quality are varying a lot. Therefore, the establishment of a Swiss Sarcoma Cohort Study (SwissSARCOS) is instrumental in improving the quality of treatment, which has already been shown in other countries. If all patients are registered including their respective follow-up, the type of treatment can be registered and the various geographic regions can be compared with respect to patients' outcome. It can be expected that the awareness of treating a sarcoma patient according to international standards will be increased, for the benefit of the patient. Importantly, such registration will provide the base to participate in international studies in form of clinical trials, which is a prerequisite and also requested by the HSM, and will further improve the quality of the therapy of sarcoma patients in Switzerland. Such cohort study will also allow to assess the prevalence of sarcoma types in Switzerland, with its associated regional differences. Because of its rarity, registering all sarcoma types in Switzerland will bring together sizeable numbers and therefore will provide the base for numerous outcome studies. Because it is known that sarcomas are extremely heterogeneous and are molecularly defined, studying molecular alterations in tumour tissue is essential to advance the field. The French Sarcoma Group (Prof. JM.Coindre, F.Chibon) has started such initiative decades ago and are therefore leaders in this field. The investigators therefore speculate that SwissSARCOS ultimately will also provide a strong base to establish a sarcoma tissue bank which allows the study of molecular alterations on the one hand, but on the other hand to correlate these findings with clinical outcome. For these reasons outlined above, the establishment of SwissSARCOS is crucial to improve treatment quality of sarcoma patients in Switzerland.

The specific questions addressed within the first 2-year time period include: 1.) what is the prevalence of which sarcoma type in Switzerland; 2.) What is the quality of the (correct) diagnosis?; 3.) What is the quality of treatment?; 4.) What is the outcome (survival, local recurrence, metastasis etc.) of sarcoma patients in Switzerland? Complete identification and thorough assessment of the basic clinical parameters ("minimal data set") of sarcoma patients treated in Switzerland in a prospective manner will allow to improve the quality of patient care as outlined above. This is also in line with the national strategy to register all cancer patients. Therefore, this effort is very timely and has direct impact on public health issues. As shown for other cohort studies in Switzerland (e.g. HIV), such assessment of clinical parameters has widespread implications not only on the standard of patient care, but also on addressing important clinical research questions, thereby becoming a very relevant health care issue. Through such coordinated and orchestrated approach, Switzerland will become a key player for international collaborations to improve the treatment for sarcoma patients. It is very clear that it cannot be expected to include every single patient diagnosed with sarcoma of whole Switzerland right from the beginning. Obviously, it is the intention to first set a strong base with national key players and institutions, and then to strengthen this collaborative network to become a national instrument. The network of national key players and institutions should allow to bring all the regional efforts to a national level. The Sarcoma Center Zurich (www.sarkomzentrum.ch) is certified as a center of excellence by the German Cancer Society (DKG= Deutsche Krebsgesellschaft) since December 2013, the very first one in Switzerland. The Sarcoma Center in Zurich bases on the instrumental efforts of the cantonal government ("Regierungsrat") to specifically support the multidisciplinary team approach in musculoskeletal oncology, both on the clinical and research side since 2010 by the HSM program (www.sarkomboard.ch). Over the years, collaboration with all major regional hospitals in Switzerland was set up. All the collaborators of these hospitals have assembled to strengthen the goal to build up a Sarcoma Cohort Study. For that reasons the Sarcoma Center Zurich has the lead for this multicentre study and the ethic committee of Zurich is chosen as the leading committee.

Future: Molecular analyses of sarcoma tissue are the key for the advancement of the treatment strategies of sarcoma patients. Again based on the HSM program funded by the cantonal government in Zurich, tumour tissue specimens as well as blood is collected and stored of each single patient operated for a sarcoma in Zurich. This allows addressing fundamental molecular questions via TMA (tissue microarray analyses), the characterization of molecular markers, both in-vitro and in-vivo, proteomic diagnostic analyses, and novel targeted treatment approaches (please refer to www.sarkomzentrum.ch). It is foreseen that in the second phase of this grant project -and after having established the fundamentals of the national cohort study- to extend the efforts to not only gather patient data ("minimal data set"), but also tumour tissue/blood from the sarcoma patients treated in Switzerland.

In a further next step, and again based on these efforts outlined above with a nationally well documented patient cohort, the base will be set to participate in international clinical trials to test for example novel drug compounds or novel diagnostic imaging tools.

National Swiss Sarcoma Cohort Study

Prospective Multi-center National Swiss Sarcoma Cohort Study

Assessed data shall be shared with the National Institute for Cancer Epidemiology an Registration and the cantonal cancer registers

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Tracked Ultrasound for Patient Registration in Surgical Navigation During Abdominal Cancer Surgery	NCT05637359	Abdominal Cance...	Tracked ultraso...	18 Years -	The Netherlands Cancer Institute
Enrollment on the Childhood Cancer Research Network (CCRN) of the Children s Oncology Group	NCT01117168	Pediatric Cance... Leukemia Sarcoma Brain Tumors		- 18 Years	National Institutes of Health Clinical Center (CC)
Vessel-based Ultrasound Registration	NCT05637346	Abdominal Cance...	Intra-operative...	18 Years -	The Netherlands Cancer Institute
Tracked Ultrasound for Patient Registration in Surgical Navigation During Abdominal Cancer Surgery	NCT05637359	Abdominal Cance...	Tracked ultraso...	18 Years -	The Netherlands Cancer Institute
Tracked Ultrasound for Patient Registration in Surgical Navigation During Abdominal Cancer Surgery	NCT05637359	Abdominal Cance...	Tracked ultraso...	18 Years -	The Netherlands Cancer Institute
National Swiss Sarcoma Cohort Study	NCT02775799	Sarcoma Neoplasm of Bon... Neoplasms Soft Tissue Sar... Soft Tissue Neo... Sarcoma of Bone	Registration	-	Balgrist University Hospital
Vessel-based Ultrasound Registration	NCT05637346	Abdominal Cance...	Intra-operative...	18 Years -	The Netherlands Cancer Institute

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