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A proof of concept study for [18F]FB-IL2 PET imaging of infiltrating T cells after renal transplantation; a diagnostic tool for acute rejection

A proof of concept study for [18F]FB-IL2 PET imaging of infiltrating T cells after renal transplantation; a diagnostic tool for acute rejection - IL2 PET for renal transplant rejection

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON44399
Enrollment
20
Registered
2017-12-11
Start date
2018-02-13
Completion date
Unknown
Last updated
2024-07-15

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

Conditions

Renal transplant rejection

Interventions

None listed

Sponsors

Universitair Medisch Centrum Groningen
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Female or male aged between 18 and 80 years. • The patient understands the purpose and risks of the study and has given written informed consent to participate in the study. • All patients will have a clinical indication for renal biopsy.

Exclusion criteria

Exclusion criteria: • Patients with multiple-organ transplants. • Female patients who are pregnant or unwilling to use adequate contraception during the study. • Altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent. • A clinical reason for an immediate start of a therapeutic intervention with immunosuppressive medication.

Design outcomes

Primary

MeasureTime frame
Uptake of [18F]FB-IL2 in the transplanted kidney will be correlated to inflammatory infiltrate and histological BANFF score.

Secondary

MeasureTime frame
Uptake of [18F]FB-IL2 in the transplanted kidney will be correlated to renal function as measured by 24-hours urine clearance and MDRD. Uptake of [18F]FB-IL2 in the transplanted kidney will be correlated to T-cell subpopulations in urine and blood. Uptake of [18F]FB-IL2 in the transplanted kidney will be correlated to outcome after kSORT analysis in blood.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)