Neoplasms

All Conditions

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Skin and Connective Tissue Diseases

Mouth and Tooth Diseases

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Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

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Carcinoma, Basal Cell

Sarcoma

Skin Neoplasms

Mouth Neoplasms

Soft Tissue Neoplasms

Sarcoma, Kaposi

Skin Diseases

Head and Neck Neoplasms

Mouth Diseases

Stomatognathic Diseases

Soft Tissue Sarcoma

Oral Cancer

Kaposi Sarcoma

Tongue Cancer

Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds

An intratumoral insertion of a seed(s), loaded with Radium-224, securely fixed in the seeds. The seeds release by recoil into the tumor short-lived alpha-emitting atoms.

Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)

Liron Dimnik

Aron Popovtzer, MD

Aron Popovtzer

A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for superficial cutaneous, mucosal or soft tissue neoplasia

This will be a prospective, open label, single arm, controlled study, assessing the safety and efficacy of diffusing alpha emitters radiation therapy (DaRT) delivered through radioactive seeds inserted into the tumor.

This approach combines the advantages of local intratumoral irradiation of the tumor, as used in conventional brachytherapy, with the power of the alpha radiation emitting atoms, that will be introduced in quantities considerably lower than radiation therapy already used in patients.

Superficial lesions with histopathological confirmation of malignancy will be treated using DaRT seeds.

Reduction in tumor size 70 days after DaRT insertion will be assessed. Safety will be assessed by the incidence, severity and frequency of all Adverse Events (AE).

Alpha Radiation Emitters Device (DaRT) for the Treatment of Cutaneous, Mucosal or Superficial Soft Tissue Neoplasia

A Safety and Effectiveness Study of Intratumoral Diffusing Alpha Radiation Emitters for the Treatment of Malignant Cutaneous, Mucosal or Superficial Soft Tissue Neoplasia

All Adverse Events (AE) related and unrelated to the study treatment

Assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1)

The incidence, frequency, severity and causality of acute adverse events related to the DaRT treatment according to Common Terminology and Criteria for adverse events (CTCAE) version 5.0.

Assessment by localization of the DaRT seeds in the tumor using CT imaging on the day of DaRT insertion

Assessment of patient reported health-related Quality of Life outcome after DaRT, using QoL questionnaire Skindex-16 questionnaire score

Assessment of patient reported health-related Quality of Life outcome after DaRT, using QoL questionnaire Skin Cancer Index (SCI) questionnaire score

Time elapsed from response to disease progression

Alpha Tau Medical LTD.

Recurrence

Adi Cohen

Naama Barel

Aron Popovtzer, M.D

This will be a prospective, open label, single arm, controlled study, assessing the safety and efficacy of re-treatment with diffusing alpha emitters radiation therapy (DaRT) delivered through radioactive seeds inserted into the tumor.

This approach combines the advantages of local intratumoral irradiation of the tumor, as used in conventional brachytherapy, with the power of the alpha radiation emitting atoms, that will be introduced in quantities considerably lower than radiation therapy already used in patients.

Superficial lesions with histopathological confirmation of either recurrent or persistent disease following DaRT treatment. .

Reduction in tumor size 70 days after DaRT insertion will be assessed. Safety will be assessed by the incidence, severity and frequency of all Adverse Events (AE).

Retreatment With Intratumoral Diffusing Alpha Radiation Emitters

A Safety and Efficacy Study of Retreatment With Intratumoral Diffusing Alpha Radiation Emitters

Incidence of all Adverse Events (AE) related and unrelated to the study treatment.

Frequency, severity and causality of acute adverse events related to the DaRT treatment. Adverse events will be assessed and graded according to Common Terminology and Criteria for adverse events (CTCAE) version 5.0.

Will be assessed as the number of complete responses, partial responses and stable disease divided by the total numbers of tumors treated.

Tomer Charas, MD

Alpha Radiation Emitters Device (DaRT) for the Treatment of Cutaneous, Mucosal or Superficial Soft Tissue Neoplasia.

Assessment of the rate of malignant cutaneous, mucosal or superficial soft tissue tumors response using the Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1)

The incidence, frequency, severity and causality of acute adverse events related to the DaRT treatment

Assessment of the reduction in tumor volume based on CT / PET-CT measured tumor volume

Assessment of the DaRT seeds placement by localization of the DaRT seeds in the tumor using CT imaging on the day of DaRT insertion.

Assessment of patient reported health-related Quality of Life outcome after DaRT, using QoL questionnaire Skindex-16 questionnaire score. An overall score ranging from 0 (best) to 100 (worst).

Assessment of patient reported health-related Quality of Life outcome after DaRT, using QoL questionnaire Skin Cancer Index (SCI) questionnaire score. An overall score ranging from 0 (best) to 100 (worst).

Device: Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)

Laura Eibenschuz, MD

This will be a prospective, open label, single arm, controlled study, assessing the safety and efficacy of diffusing alpha emitters radiation therapy (DaRT) delivered through radioactive seeds inserted into the tumor.

This approach combines the advantages of local intratumoral irradiation of the tumor, as used in conventional brachytherapy, with the power of the alpha radiation emitting atoms, that will be introduced in quantities considerably lower than radiation therapy already used in patients.

Superficial lesions with histopathological confirmation of malignancy will be treated using DaRT seeds.

Reduction in tumor volume and evaluation the percent of necrotic tissue in the tumor 30-45 days after DaRT seeds insertion (15-30 days after seed removal) will be assessed. Safety will be assessed by the cumulative incidence, worst severity and frequency of adverse events (AEs) observed including the follow-up period.

Alpha Radiation Emitters Device for the Treatment of Cutaneous, Mucosal and Superficial Soft Tissue Neoplasia (DaRT)

A Safety and Preliminary Effectiveness Study of Intratumoral Diffusing Alpha Radiation Emitters on Cutaneous, Mucosal and Superficial Soft Tissue Neoplasia

Evaluate the effectiveness of the DaRT treatment, in terms of percent of necrotic tissue present in the remaining tumor tissue surgically removed 15-30 days after removal of DaRT seeds.

The study primary objective is to evaluate the safety of the DaRT treatment in terms of incidence of device related Serious Adverse Events (SAE).

Evaluation on the effectiveness of the DaRT treatment, in terms of tumor volume reduction.

Musculoskeletal Diseases

Bone Neoplasms

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

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

University of Bern

Balgrist University Hospital

Noga Kurman, MD

Alpha Radiation Emitters Device for the Treatment of Cutaneous, Mucosal or Superficial Soft Tissue Neoplasia (DaRT)

Alberto Bazzocchi, MD, PhD

A retrospective evaluation of soft tissue tumors that have undergone core needle biopsy with US guidance (US-CNB)

The present study is designed to be the first step in the creation of an interdisciplinary platform collecting data on patients and procedures to provide a predictive tool to help physicians in the management of patients affected by a soft tissue lesion.

The primary aim of our work is to evaluate the diagnostic yield of US-CNB. The secondary aim is to exploit all the imaging data conventionally available at a Sarcoma Center before a biopsy on a soft tissue mass, to build a multiparametric model and score of prediction of malignancy, and eventually of biological behavior - grading.

US-Guided Biopsy in the Diagnosis of Musculoskeletal Soft-Tissue Tumors

Diagnostic Yield of Ultrasound-Guided Needle Biopsy in the Diagnosis of Musculoskeletal Soft-Tissue Tumors

Diagnostic yield will be defined as the number of diagnostic core needle biopsies divided by the total number of core needle biopsies. A diagnostic yield \> 94% will be considered sufficient to produce a sample to reach the histological diagnosis.

To determine which imaging features and biomarkers correlates with malignancy and biological behavior of soft tissue masses.

Istituto Ortopedico Rizzoli

Benign and malignant bone focal bone lesions

MR imaging

Pedro Gondim Teixieira, PhD

Gabriela Hossu, PhD

Pedro Gondim Teixeira, Prof

Alain Blum, Prof

This study aims at evaluating the value of various artificial intelligence based techniques to improve the characterization and image post-processing for patients with musculoskeletal tumors.

Comparison of values relating to the texture parameters of tumors evaluated by MRI and ultra-high resolution CT between benign and malignant lesions using histological analysis as the standard of reference.

Comparison of the diagnostic performance of texture parameters derived from different MRI sequences and ultra-high resolution CT for musculoskeletal tumor characterization.

Evaluate the impact of ultra-high resolution with respect to standard resolution on CT images Comparison of the diagnostic performance of the texture parameters for the tumor on the diagnostic performance of texture analysis derived parameters for the characterization of musculoskeletal tumors.

Evaluate the effectiveness and accuracy of automatic artificial intelligence (AI) based tumor segmentation tools.

Evaluate the use of trabecular analysis on ultra-high resolution CT images for the evaluation of tumor-bone interfaces.

Novel Imaging Techniques for the Characterization of Musculoskeletal Tumors II

Novel Imaging Techniques for the Characterization of Musculoskeletal Tumors II: Texture Analysis and Artificial Intelligence

Histologic determination of lesion aggressiveness (benign versus malignant) on core biopsy material

Histologic grade of the sarcomas included in the study population with surgical resection material

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Alpha Radiation Emitters Device (DaRT) for the Treatment of Cutaneous, Mucosal or Superficial Soft Tissue Neoplasia	NCT04534127	Skin Cancer Mucosal Neoplas... Soft Tissue Neo...	Radiation: Diff...	18 Years -	Alpha Tau Medical LTD.
Retreatment With Intratumoral Diffusing Alpha Radiation Emitters	NCT04540588	Skin Cancer Mucosal Neoplas... Soft Tissue Neo...	Radiation: Diff...	18 Years -	Alpha Tau Medical LTD.
Alpha Radiation Emitters Device (DaRT) for the Treatment of Cutaneous, Mucosal or Superficial Soft Tissue Neoplasia.	NCT03889899	Skin Cancer Mucosal Neoplas... Soft Tissue Neo...	Radiation: Diff...	18 Years -	Alpha Tau Medical LTD.
Alpha Radiation Emitters Device for the Treatment of Cutaneous, Mucosal and Superficial Soft Tissue Neoplasia (DaRT)	NCT03886181	Skin Cancer Mucosal Neoplas... Soft Tissue Neo...	Device: Radiati...	18 Years -	Alpha Tau Medical LTD.
National Swiss Sarcoma Cohort Study	NCT02775799	Sarcoma Neoplasm of Bon... Neoplasms Soft Tissue Sar... Soft Tissue Neo... Sarcoma of Bone	Registration	-	Balgrist University Hospital
Alpha Radiation Emitters Device for the Treatment of Cutaneous, Mucosal and Superficial Soft Tissue Neoplasia (DaRT)	NCT03886181	Skin Cancer Mucosal Neoplas... Soft Tissue Neo...	Device: Radiati...	18 Years -	Alpha Tau Medical LTD.
Alpha Radiation Emitters Device for the Treatment of Cutaneous, Mucosal or Superficial Soft Tissue Neoplasia (DaRT)	NCT03737734	Skin Cancer Mucosal Neoplas... Soft Tissue Neo...	Radiation: Diff...	18 Years -	Alpha Tau Medical LTD.
US-Guided Biopsy in the Diagnosis of Musculoskeletal Soft-Tissue Tumors	NCT03452644	Soft Tissue Neo... Soft Tissue Sar... Soft Tissue Mas... Soft Tissue Les...		-	Istituto Ortopedico Rizzoli
US-Guided Biopsy in the Diagnosis of Musculoskeletal Soft-Tissue Tumors	NCT03452644	Soft Tissue Neo... Soft Tissue Sar... Soft Tissue Mas... Soft Tissue Les...		-	Istituto Ortopedico Rizzoli
Alpha Radiation Emitters Device (DaRT) for the Treatment of Cutaneous, Mucosal or Superficial Soft Tissue Neoplasia.	NCT03889899	Skin Cancer Mucosal Neoplas... Soft Tissue Neo...	Radiation: Diff...	18 Years -	Alpha Tau Medical LTD.
Novel Imaging Techniques for the Characterization of Musculoskeletal Tumors II	NCT04394052	Soft Tissue Neo... Bone Neoplasm	MR imaging	18 Years -	Central Hospital, Nancy, France

Spots Global Cancer Trial Database for soft tissue neoplasm