Neoplasms

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All Conditions

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Genital Diseases, Male

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Female Urogenital Diseases and Pregnancy Complications

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Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

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Lung Diseases

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Breast Diseases

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Quality of Life

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All Drugs and Chemicals

Liver Extracts

Radiation therapy on the CE marked and FDA approved MR-Linac

Radiation therapy

Tessa Leer

Tom Colonias

Clifton D Fuller

William A Hall

Sweet Ping

Robbe van den Begin

Arjun Sahgal

Michael Velec

Tine Schytte

Cihan Gani

Stefano Magrini

Filippo Alongi

Marlies N Nowee

Paul Jeene

Peter de Boer

Linda Kerkmeijer

Helena M Verkooijen, Prof, Dr

Shaista Hafeez

Ananya Choudhury

The Multi-OutcoMe EvaluatioN of radiation Therapy Using the Unity MR-Linac Study (MOMENTUM) is a multi-institutional, international registry facilitating evidenced based implementation of the Unity MR-Linac technology and further technical development of the MR-Linac system with the ultimate purpose to improve patients' survival, local, and regional tumor control and quality of life.

Rationale: Radiation therapy has become indispensable in cancer treatment. However, it is associated with severe side effects. Innovation in radiation therapy has resulted in the development of MR-guided radiation therapy (MRGRT) which allows high precision radiotherapy under real time MR visualization. High precision MRGRT has the potential of dose escalation and margin reduction and may potentially lead to higher cure rates and less toxicity. MRGRT can be delivered by the MRI guided Linear Accelerator (MR-Linac) which integrates a state-of-the-art linear accelerator, 1.5T diagnostic quality MRI and an online adaptive workflow.

Objective: The Multi-OutcoMe EvaluatioN of radiation Therapy Using the MR-Linac Study (MOMENTUM) aims to accelerate the technical and clinical development of Anatomic and Biologic MRGRT and facilitate the evidence-based introduction of the MR-Linac into clinical practice. In MOMENTUM, technical and clinical data are gathered in order to optimize software, evaluate treatment outcomes, toxicities and progression free, disease free, and overall survival per disease site, and create a repository of anatomical and biological MR sequences to develop new features.

Study design: A multi-institutional, international observational cohort study. Study population: Cancer patients ≥ 18 years receiving treatment and/or imaging on an MR-Linac machine are eligible for enrollment.

Main study parameters/endpoints: MOMENTUM will collect technical and clinical patient data. The technical patient data is defined as data generated by (the use of) the MR-Linac and will include data collection during scans performed during routine care as well as research MRIs. Clinical data will be categorized into six classes: demographic, disease characteristics, treatment classifiers, toxicity outcomes, cancer control outcomes and PROs.

The MOMENTUM Study: The Multiple Outcome Evaluation of Radiation Therapy Using the MR-Linac Study

The Multiple Outcome Evaluation of Radiation Therapy Using the MR-Linac Study

Progression free survival of participating patients will be obtained from the hospital information systems. Patient follow-up is conducted to local standard of care practices.

Overall survival of participating patients will be obtained from the hospital information systems. Patient follow-up is conducted to local standard of care practices.

Disease-free survival of participating patients will be obtained from the hospital information systems. Patient follow-up is conducted to local standard of care practices.

Patient reported health related quality of life is captured through a questionnaire the Generic European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30. They include 5 functional scales (physical, role, emotional, cognitive and social), three symptom scales, a global health scale, and six single items. All of these scales and items measures range in score from 0 to 100. A high score on functional or global health status scale represents a high/healthy level of functioning. A high score for a symptom scale represents a high level of symptomatology.

Patient reported health related quality of life is captured through a questionnaire the Generic European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30. They include 5 functional scales (physical, role, emotional, cognitive, and social), three symptom scales, a global health scale, and six single items. All of these scales and items measures range in score from 0 to 100. A high score on functional or global health status scale represents a high/healthy level of functioning. A high score for a symptom scale represents a high level of symptomatology.

Generic patient reported quality of life is captured by The EuroQol (EQ)-5D-5L questionnaire. This includes a descriptive system questionnaire and visual analogue scale (VAS). The descriptive system scores five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) from 1 to 5 where 1 means having no problems, and 5 means extreme problems or unable to participate. The digits can be combined in a 5-digit code to describe the overall health status. For example, 12111. The VAS records the overall current health on a vertical visual analogue scale from 0 to 100, respectively 'the worst health you can imagine' to 'the best health you can imagine'.

Disease-specific patient reported quality of life is captured by a tumor specific EORTC QLQ questionnaire. (Brain-BN20, Breast-BR23, Bladder-BLM30, colorectal-CR29, Gynecological-CX24\&VU34, Head and Neck-HN35, liver-HCC18 (primary) and -LMC21 (metastasis), lung-LC13, esophageal-OES18, prostate-PR2, pancreas-PAN26). They all include a different set of functional scales and symptom scales. All of these scales and items measures range in score from 0 to 100. A high score on functional scale represents a high/healthy level of functioning. A high score for a symptom scale represents a high level of symptomatology.

Disease-specific toxicity is obtained from the hospital information system. Toxicities are reported according to the Common Terminology Criteria for Adverse Events (CTCAE) dictionary.

Clinical tumor response in participating patients is obtained from hospital information systems. Clinical patient follow-up and re-staging procedures are conducted to local standard of care practices.

Pathological tumor response in participating patients who undergo surgery are obtained from hospital information systems. Clinical patient follow-up and re-staging procedures are conducted to local standard of care practices.

Disease-specific toxicity is obtained from the hospital information system.

The Netherlands Cancer Institute

Sunnybrook Health Sciences Centre

M.D. Anderson Cancer Center

The Christie NHS Foundation Trust

Royal Marsden NHS Foundation Trust

Medical College of Wisconsin

Elekta Limited

Odense University Hospital

Radboud University Medical Center

Radiotherapiegroep

Jules Bordet Institute

University Hospital Tuebingen

Radiotherapeutic Institute Friesland

Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

IRCCS Sacro Cuore Don Calabria di Negrar

Austin Health

Princess Margaret Hospital, Canada

Università degli Studi di Brescia

UMC Utrecht

Prof. Dr.

Carcinoma

Adenocarcinoma

Carcinoma, Squamous Cell

Esophageal Squamous Cell Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Patients undergoing esophagectomy with ActivSight (n=70)

Use of ActivSight in patients undergoing laparoscopic or robot assisted esophagectomy.

ActivSight

Peter Kim, MD

Chris McCulloh, MD

Julie Ward, RN, BSN

Inderpal S Sarkaria, MD

James D Luketich, MD

Meredith Schwarz, RN, MSN

Blair A Jobe, MD

Kirsten Newhams, MD, MPH

ActivSight™ combines an innovative form factor and proprietary software to deliver precise, objective, real-time visualization of blood flow and tissue perfusion intraoperatively for laparoscope-based surgery. A small adaptor that fits between any existing laparoscope and camera systems and a separate light source placed along any current commercial system will deliver objective real-time tissue perfusion and blood flow information intraoperatively.

Primary Objective: To determine the feasibility of ActivSight™ in detecting and displaying tissue perfusion and blood flow in the conduit and foregut anastomoses in esophageal resection/reconstructive surgery. The investigators will compare the precision and accuracy among the naked eye inspection, ICG and LSCI in assessing the vascularity of the conduit.

Design:

* This is a prospective interventional cross-over study where ActivSight™ will be used in sequence to the standard practice of visualizing perfusion status of the conduit using the naked eye visual inspection and ICG during esophageal resection.
* Feasibility will be determined by technically successful completion of intended visualization.
* Safety will be determined through clinical assessments and evaluation of any adverse event.
* Assessment of preliminary efficacy will be performed through analysis of any intraoperative decisions made based on visual display as compared to standard endoscopic approach, or non-inferiority to ICG-based visualization and usability.
* Patient outcome and follow up to Postoperative day 28 will be monitored for clinical outcome.
* Target enrollment for the assessment of esophageal anastomoses is a total of seventy patients powered to detect \~ 2-3 cm discordance between ICG and LSCI lines of demarcation between well vascularized and less vascularized sites in the gastric conduit. Since ActivSight™ can detect the difference of \> 2 cm between perfused versus less perfused in comparison to ICG with 80 % confidence at p\<0.05 in a sample size of n = 21, the investigators estimate that the study will require an accrual of 63 patients. With potential unforeseen dropout and mortality, the investigators will recruit a total of 70 patients for the proposed study.

Target enrollment for the assessment of esophageal anastomoses is a total of 70 patients powered to detect \~ 2-3 cm discordance between ICG and LSCI lines of demarcation between well vascularized and less vascularized site in the gastric conduit. Since ActivSight™ can detect the difference of \> 2 cm between perfused versus less perfused in comparison to ICG with 80 % confidence at p\<0.05 in a sample size of n = 21, the investigators estimate that the study will require an accrual of 63 patients. With potential unforeseen dropout and mortality, the investigators recruit a total of 70 patients for the proposed study.

Utility and Usability of ActivSight™ Laser Speckle Imaging in Visualization of Tissue Perfusion and Blood Flow During Esophageal Surgery in Humans

To determine safety of ActivSight™ in patients undergoing esophageal surgery, as defined through clinical assessments and evaluation of use related adverse events intraoperatively and a routine follow up at 28 days following surgery. ActivSight™ will be deemed safe if no hardware (adaptor or light source)-related major (serious) adverse event is encountered in the treated patients and if less than 2 hardware-related minor adverse events are encountered.

Adverse events will be summarized descriptively and tabulations on the type, severity, and relationship to application will be performed and any changes of outcomes from baseline on follow up will be examined using the nonparametric Wilcoxon rank test.

Rate on a scale of 1-5 (1 = Difficult to use or Unsatisfied - 5 = no training required or very satisfied): How easy was ActivSight to set up?

Rate on a scale of 1-5 (1 = Difficult to use or Unsatisfied - 5 = no training required or very satisfied): How specifically did ActivSight display the intended field and the target tissue of interest?

Rate on a scale of 1-5 (1 = Difficult to use or Unsatisfied - 5 = no training required or very satisfied): How was the display quality of ActivSight on the intended field and target tissue of interest?

Specificity of display will serve as an outcome for feasibility. Yes/No question for surgeon: "Does the perfusion information displayed by ActivSightTM reflect the expected pattern of blood flow interruption?"

Likert scale ratings will serve as an outcome for feasibility. Scale 1-5 question (1=strongly disagree, 2=slightly disagree, 3=neutral, 4=slightly agree, 5=strongly agree): "ActivSightTM was easy to use while operating."

Likert scale ratings will serve as an outcome for feasibility. Scale 1-5 question (1=strongly disagree, 2=slightly disagree, 3=neutral, 4=slightly agree, 5=strongly agree): "ActivSightTM was easy to set up for the procedure."

Likert scale ratings will serve as an outcome for feasibility. Scale 1-5 question (1=strongly disagree, 2=slightly disagree, 3=neutral, 4=slightly agree, 5=strongly agree):

Yes/No if surgeons changed intraoperative planning/decisions based on ActivSight™, with additional details (what did they change and why) requested if yes.

ActivSightTM ability to display perfusion at a tissue level during gastrointestinal anastomoses is measured by the following Yes/No question for the surgeon: "Does ActivSightTM display tissue perfusion of the anatomy during anastomoses in comparison to ICG?"

ActivSightTM ability to display blood vessels during gastrointestinal anastomoses is measured by the following Yes/No question for the surgeon: "Does ActivSightTM display vascularity of the anatomy during anastomoses in comparison to ICG?"

University of Pittsburgh Medical Center

West Penn Allegheny Health System

Activ Surgical

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
The MOMENTUM Study: The Multiple Outcome Evaluation of Radiation Therapy Using the MR-Linac Study	NCT04075305	Oncology Breast Cancer Prostate Cancer Gynecologic Can... Brain Tumor Brain Cancer Gynecologic Tum... Prostate Tumor Prostate Neopla... Breast Tumor Radiation Toxic... Quality of Life Rectal Cancer Rectal Tumor Rectal Neoplasm... Lung Cancer Lung Tumor Lung Neoplasm Esophageal Canc... Esophagus Cance... Esophageal Tumo... Esophageal Neop... Esophagus Tumor Esophagus Neopl... Pancreatic Canc... Pancreatic Tumo... Pancreatic Neop... Head and Neck C... Head and Neck N... Head and Neck T... Tumor Neoplasms Bladder Cancer Bladder Neoplas... Liver Cancer Liver Neoplasms Liver Metastase... Oligometastases	Radiation thera...	18 Years -	UMC Utrecht
Utility and Usability of ActivSight™ Laser Speckle Imaging in Visualization of Tissue Perfusion and Blood Flow During Esophageal Surgery in Humans	NCT05591053	Esophagus Cance... Esophageal Canc... Esophageal Neop... Esophageal Dise... Esophageal Aden... Esophageal Squa... Esophagus SCC Esophagus Tumor Esophagus Adeno... Esophagus Neopl...	ActivSight	18 Years -	Activ Surgical

Spots Global Cancer Trial Database for esophagus tumor