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MRHeatflow-Study: study of changes in pelvic blood flow during radiotherapy with or without hyperthermia in patients with a pelvic tumor

MRHeatflow-Study: an observational study of changes in pelvic circulation during radiotherapy with or without hyperthermia in patients with cancer of the small pelvis - MRHeatflow study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON54245
Enrollment
40
Registered
2021-08-06
Start date
2024-02-15
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

gynaecological cancer, pelvic cancer

Interventions

We are investigating the added value of quantitative MRI. In particular, we are measuring perfusion and diffusion properties of tissue. The MRI sequences include:&nbsp
Intra-voxel incoherent motion diffusion-weighted MRIDynamic contrast-enhanced MRIT2* relaxometrie

Sponsors

Amsterdam UMC
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: All adult patients (18 years or older) with pelvic cancer who are possibly eligible for curative radiotherapy with or without hyperthermia - 18 years or older - histologically confirmed primary pelvic tumour, - possibly eligible for primary radiotherapy (with or without chemotherapy and/or hyperthermia) - able to understand and read Dutch or English, - written informed consent (Dutch or English)

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - all who do not comply to the inclusion criteria - those with a contra-indication for MRI (i.e. MRI incompatible metal implants, pacemaker, severe claustrophobia) - those with a contra-indication for MRI-contrast agent (i.e. known allergic reaction, poor functioning of the kidneys eGFR

Design outcomes

Primary

MeasureTime frame
The primary end-point is to show feasibility of perfusion MRI by determining significant changes in blood circulation in HT and RT patients. Furthermore, several secondary end-points aim at using the data for hypothesis generating and retrieving the essential preliminary data to allow for designing more in depth studies into using perfusion MRI as biomarker for HT efficacy.

Secondary

MeasureTime frame
See above.

Countries

Netherlands

Contacts

Public ContactL. J. A. Stalpers

Amsterdam UMC

l.stalpers@amsterdamumc.nl020-5664231

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)