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Hepatic NET metastasis embolization biomarker evaluation

Hepatic NET metastasis embolization biomarker evaluation - Hepatic NET metastasis embolization biomarker evaluation

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON44840
Enrollment
30
Registered
2016-01-06
Start date
2016-04-07
Completion date
Unknown
Last updated
2024-04-23

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

Conditions

Neuro endocrine tumor

Interventions

Blood sampling schedule • Whole blood will be collected at baseline (defined as prior to SIRT/embolisation/ablative moment)
three base-line bloods. • Blood samples before and 15 mins after each embolic or ablative event during the course of the procedure and day 5. • Whole blood collected at each patient visit for the du

Sponsors

Nederlands Kanker Instituut
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • >= 18 years old with metastatic well differentiated neuroendocrine tumor of gastro-enteropancreatic origin who will undergo a local ablative treatment or HAE/SIRT . • Patients have measurable disease • WHO performance status 0-2 • Life expectancy more than 3 months • Use of the standard embolization/RFA NET-NKI protocol

Exclusion criteria

Exclusion criteria: 1. Known history of HIV seropositivity. 2. contraindication for liverembolisation, RFA/MWA or SIRT

Design outcomes

Primary

MeasureTime frame
Effect of hepatic metastatic embolization (HAE/SIRT) on PCR score

Secondary

MeasureTime frame
1) Determine whether blood PCR score correlates with metastasis burden 2) Determine whether ablation efficacy and PCR score correlate with assessment of tumor anatomical burden post-ablative imaging 3) Determine whether embolization/SIRT efficacy and PCR score correlate with tumor assessment anatomical burden post embolisation 4) Correlate residual tumor burden using functional tumor imaging with PCR score. 5) Evaluate stability/progression of tumor post ablation using PCR score vs. patient parameters and imaging. 6) Comparison of plasma CgA measurements with the PCR score, for the same.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)