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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04075305




Registration number
NCT04075305
Ethics application status
Date submitted
22/03/2019
Date registered
30/08/2019
Date last updated
28/09/2023

Titles & IDs
Public title
The MOMENTUM Study: The Multiple Outcome Evaluation of Radiation Therapy Using the MR-Linac Study
Scientific title
The Multiple Outcome Evaluation of Radiation Therapy Using the MR-Linac Study
Secondary ID [1] 0 0
NL66650.041.18
Universal Trial Number (UTN)
Trial acronym
MOMENTUM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Oncology 0 0
Breast Cancer 0 0
Prostate Cancer 0 0
Gynecologic Cancer 0 0
Brain Tumor 0 0
Brain Cancer 0 0
Gynecologic Tumor 0 0
Prostate Tumor 0 0
Prostate Neoplasm 0 0
Breast Tumor 0 0
Radiation Toxicity 0 0
Quality of Life 0 0
Rectal Cancer 0 0
Rectal Tumor 0 0
Rectal Neoplasms 0 0
Lung Cancer 0 0
Lung Tumor 0 0
Lung Neoplasm 0 0
Esophageal Cancer 0 0
Esophagus Cancer 0 0
Esophageal Tumor 0 0
Esophageal Neoplasm 0 0
Esophagus Tumor 0 0
Esophagus Neoplasm 0 0
Pancreatic Cancer 0 0
Pancreatic Tumor 0 0
Pancreatic Neoplasms 0 0
Head and Neck Cancer 0 0
Head and Neck Neoplasms 0 0
Head and Neck Tumor 0 0
Tumor 0 0
Neoplasms 0 0
Bladder Cancer 0 0
Bladder Neoplasm 0 0
Liver Cancer 0 0
Liver Neoplasms 0 0
Liver Metastases 0 0
Oligometastases 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate
Cancer 0 0 0 0
Pancreatic
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Cancer 0 0 0 0
Head and neck
Cancer 0 0 0 0
Bladder - transitional cell cancer
Cancer 0 0 0 0
Oesophageal (gullet)
Cancer 0 0 0 0
Brain
Cancer 0 0 0 0
Liver
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell
Cancer 0 0 0 0
Breast
Cancer 0 0 0 0
Ovarian and primary peritoneal
Cancer 0 0 0 0
Womb (Uterine or endometrial cancer)
Cancer 0 0 0 0
Cervical (cervix)

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Other - Radiation therapy

Brain cancer -

Lung cancer -

Esophageal cancer -

Breast Cancer -

Head and Neck Cancer -

Pancreatic cancer -

Gynecological cancer -

Rectal cancer -

Prostate cancer -

Bladder cancer -

Oligometastases -

Liver cancer -

Other types of cancer -


Treatment: Other: Radiation therapy
Radiation therapy on the CE marked and FDA approved MR-Linac
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free Survival
Timepoint [1] 0 0
3 months after MR-Linac treatment
Primary outcome [2] 0 0
Progression-free Survival
Timepoint [2] 0 0
6 months after MR-Linac treatment
Primary outcome [3] 0 0
Progression-free Survival
Timepoint [3] 0 0
24 months after MR-Linac treatment
Primary outcome [4] 0 0
Survival
Timepoint [4] 0 0
3 months after MR-Linac treatment
Primary outcome [5] 0 0
Survival
Timepoint [5] 0 0
6 months after MR-Linac treatment
Primary outcome [6] 0 0
Survival
Timepoint [6] 0 0
24 months after MR-Linac treatment
Primary outcome [7] 0 0
Disease-free Survival
Timepoint [7] 0 0
3 months after MR-Linac treatment
Primary outcome [8] 0 0
Disease-free Survival
Timepoint [8] 0 0
6 months after MR-Linac treatment
Primary outcome [9] 0 0
Disease-free Survival
Timepoint [9] 0 0
24 months after MR-Linac treatment
Primary outcome [10] 0 0
Patient reported Health related quality of life (HRQoL).
Timepoint [10] 0 0
3 months after treatment.
Primary outcome [11] 0 0
Patient reported Health related quality of life (HRQoL).
Timepoint [11] 0 0
6 months after treatment.
Primary outcome [12] 0 0
Patient reported Health related quality of life (HRQoL).
Timepoint [12] 0 0
12 months after treatment.
Primary outcome [13] 0 0
Patient reported Health related quality of life (HRQoL).
Timepoint [13] 0 0
24 months after treatment.
Primary outcome [14] 0 0
Patient reported Health related quality of life (HRQoL).
Timepoint [14] 0 0
3 months after treatment.
Primary outcome [15] 0 0
Patient reported Health related quality of life (HRQoL).
Timepoint [15] 0 0
6 months after treatment.
Primary outcome [16] 0 0
Patient reported Health related quality of life (HRQoL).
Timepoint [16] 0 0
12 months after treatment.
Primary outcome [17] 0 0
Patient reported Health related quality of life (HRQoL).
Timepoint [17] 0 0
24 months after treatment.
Primary outcome [18] 0 0
Patient reported tumor specific quality of life (QoL).
Timepoint [18] 0 0
3 months after treatment.
Primary outcome [19] 0 0
Patient reported tumor specific quality of life (QoL).
Timepoint [19] 0 0
6 months after treatment.
Primary outcome [20] 0 0
Patient reported tumor specific quality of life (QoL).
Timepoint [20] 0 0
12 months after treatment.
Primary outcome [21] 0 0
Patient reported tumor specific quality of life (QoL).
Timepoint [21] 0 0
24 months after treatment.
Primary outcome [22] 0 0
Acute toxicity in common toxicity criteria for adverse events (CTCAE).
Timepoint [22] 0 0
3 months after treatment.
Primary outcome [23] 0 0
Acute toxicity in common toxicity criteria for adverse events (CTCAE).
Timepoint [23] 0 0
6 months after treatment.
Primary outcome [24] 0 0
Acute toxicity in common toxicity criteria for adverse events (CTCAE).
Timepoint [24] 0 0
12 months after treatment.
Primary outcome [25] 0 0
Acute toxicity in common toxicity criteria for adverse events (CTCAE).
Timepoint [25] 0 0
24 months after treatment.
Primary outcome [26] 0 0
Clinical tumor response.
Timepoint [26] 0 0
2 year follow up.
Primary outcome [27] 0 0
Pathological tumor response.
Timepoint [27] 0 0
2 year follow up.
Primary outcome [28] 0 0
Toxicity in common toxicity criteria for adverse events (CTCAE).
Timepoint [28] 0 0
2 years

Eligibility
Key inclusion criteria
* Patient is to undergo or has completed imaging or treatment procedures on an MR-Linac;
* Patient provides written, informed consent;
* Patient is 18 years old or older.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* MRI exclusion criteria, including
* MRI contraindications as per usual clinical care, such as (possible) pregnancy; claustrophobia and metal or electronic implants not compatible with MRI.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/05/2025
Actual
Sample size
Target
8000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Austin Health - Olivia Newton-John Cancer Wellness and Research Centre - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Pennsylvania
Country [2] 0 0
United States of America
State/province [2] 0 0
Texas
Country [3] 0 0
United States of America
State/province [3] 0 0
Wisconsin
Country [4] 0 0
Belgium
State/province [4] 0 0
Brussel
Country [5] 0 0
Canada
State/province [5] 0 0
Ontario
Country [6] 0 0
Canada
State/province [6] 0 0
Toronto
Country [7] 0 0
Denmark
State/province [7] 0 0
Funen
Country [8] 0 0
Germany
State/province [8] 0 0
Tübingen
Country [9] 0 0
Italy
State/province [9] 0 0
Brescia
Country [10] 0 0
Italy
State/province [10] 0 0
Negrar
Country [11] 0 0
Netherlands
State/province [11] 0 0
Amsterdam
Country [12] 0 0
Netherlands
State/province [12] 0 0
Deventer
Country [13] 0 0
Netherlands
State/province [13] 0 0
Leeuwarden
Country [14] 0 0
Netherlands
State/province [14] 0 0
Nijmegen
Country [15] 0 0
Netherlands
State/province [15] 0 0
Utrecht
Country [16] 0 0
United Kingdom
State/province [16] 0 0
London
Country [17] 0 0
United Kingdom
State/province [17] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Other
Name
UMC Utrecht
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The Netherlands Cancer Institute
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Sunnybrook Health Sciences Centre
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
M.D. Anderson Cancer Center
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
The Christie NHS Foundation Trust
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
Royal Marsden NHS Foundation Trust
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
Medical College of Wisconsin
Address [6] 0 0
Country [6] 0 0
Other collaborator category [7] 0 0
Commercial sector/industry
Name [7] 0 0
Elekta Limited
Address [7] 0 0
Country [7] 0 0
Other collaborator category [8] 0 0
Other
Name [8] 0 0
Odense University Hospital
Address [8] 0 0
Country [8] 0 0
Other collaborator category [9] 0 0
Other
Name [9] 0 0
Radboud University Medical Center
Address [9] 0 0
Country [9] 0 0
Other collaborator category [10] 0 0
Other
Name [10] 0 0
Radiotherapiegroep
Address [10] 0 0
Country [10] 0 0
Other collaborator category [11] 0 0
Other
Name [11] 0 0
Jules Bordet Institute
Address [11] 0 0
Country [11] 0 0
Other collaborator category [12] 0 0
Other
Name [12] 0 0
University Hospital Tuebingen
Address [12] 0 0
Country [12] 0 0
Other collaborator category [13] 0 0
Other
Name [13] 0 0
Radiotherapeutic Institute Friesland
Address [13] 0 0
Country [13] 0 0
Other collaborator category [14] 0 0
Other
Name [14] 0 0
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Address [14] 0 0
Country [14] 0 0
Other collaborator category [15] 0 0
Other
Name [15] 0 0
IRCCS Sacro Cuore Don Calabria di Negrar
Address [15] 0 0
Country [15] 0 0
Other collaborator category [16] 0 0
Government body
Name [16] 0 0
Austin Health
Address [16] 0 0
Country [16] 0 0
Other collaborator category [17] 0 0
Other
Name [17] 0 0
Princess Margaret Hospital, Canada
Address [17] 0 0
Country [17] 0 0
Other collaborator category [18] 0 0
Other
Name [18] 0 0
Università degli Studi di Brescia
Address [18] 0 0
Country [18] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/study/NCT04075305
Trial related presentations / publications
Tan H, Stewart J, Ruschin M, Wang MH, Myrehaug S, Tseng CL, Detsky J, Husain Z, Chen H, Sahgal A, Soliman H. Inter-fraction dynamics during post-operative 5 fraction cavity hypofractionated stereotactic radiotherapy with a MR LINAC: a prospective serial imaging study. J Neurooncol. 2022 Feb;156(3):569-577. doi: 10.1007/s11060-021-03938-w. Epub 2022 Jan 3.
de Mol van Otterloo SR, Christodouleas JP, Blezer ELA, Akhiat H, Brown K, Choudhury A, Eggert D, Erickson BA, Faivre-Finn C, Fuller CD, Goldwein J, Hafeez S, Hall E, Harrington KJ, van der Heide UA, Huddart RA, Intven MPW, Kirby AM, Lalondrelle S, McCann C, Minsky BD, Mook S, Nowee ME, Oelfke U, Orrling K, Sahgal A, Sarmiento JG, Schultz CJ, Tersteeg RJHA, Tijssen RHN, Tree AC, van Triest B, Hall WA, Verkooijen HM. The MOMENTUM Study: An International Registry for the Evidence-Based Introduction of MR-Guided Adaptive Therapy. Front Oncol. 2020 Sep 7;10:1328. doi: 10.3389/fonc.2020.01328. eCollection 2020.
Public notes

Contacts
Principal investigator
Name 0 0
Helena M Verkooijen, Prof, Dr
Address 0 0
Universitair Medical Centre Utrecht
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Tessa Leer
Address 0 0
Country 0 0
Phone 0 0
T +31 (0)88 75 63707
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04075305