Skip to content

Pharmacodynamic assessment and exploration of cerebral changes in relation to fatigue of antiangiogenic treatment in cancer patients

Pharmacodynamic assessment and exploration of cerebral changes in relation to fatigue of antiangiogenic treatment in cancer patients - Platelets and MRI

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON35245
Enrollment
40
Registered
2007-05-29
Start date
2007-09-11
Completion date
Unknown
Last updated
2024-08-12

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

Conditions

cancer Solid tumors

Interventions

None listed

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: The patient will have a histologically or cytologically documented solid tumor The patient will start with antiangiogenic treatment as monotherapy The patient must be >= 18 years of age The patient will have not received any chemotherapy or biological therapy within the last 28 days and has recovered from any acute effects The patients is able to safely donate approximately 120ml of blood in a 6 week period The patient is able to undergo three MRI assessments in a 6 week period

Exclusion criteria

Exclusion criteria: The patient has received treatment within the last 28 days with a drug that has not received regulatory approval for any indication at the time of study entry. Metal implants including a pacemaker, aneurysm clips of stainless steel, implanted insulin pump, cochlea implants, specific heart valves, which are a contraindication for MRI. Metal splinter in the eye Implanted vascular access device is approved if it is not in use. Claustrophobia, not able to undergo MRI. Clinical signs of brain or meningeal metastases.

Design outcomes

Primary

MeasureTime frame
To determine whether antiangiogenic treatment 1) impairs platelet biology and 2) induces MRI detectable cerebral changes

Secondary

MeasureTime frame
1) a. growth factor concentrations in platelets, plasma and serum b. Concentration of angiogenesis inhibitors in platelets 2) a. Fatigue score

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)