Holmium-166-radioembolization in NET After Lutetium-177-dotatate; an Efficacy Study (HEPAR_Plus)
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|ClinicalTrials.gov Identifier: NCT02067988|
Recruitment Status : Recruiting
First Posted : February 20, 2014
Last Update Posted : October 27, 2016
|Condition or disease||Intervention/treatment||Phase|
|Neuroendocrine Tumors||Device: Holmium-166 microspheres hepatic radioembolization.||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Adjuvant Hepatic Holmium-166-radioembolization in Patients With Unresectable Liver Metastases of Neuroendocrine Origin, Who Have Been Treated With Lutetium-177-dotatate|
|Study Start Date :||February 2014|
|Estimated Primary Completion Date :||January 2018|
|Estimated Study Completion Date :||January 2018|
Experimental: Treatment arm
Holmium-166 microspheres hepatic radioembolization, adjuvant to systemic 177Lu-dotatate.
Device: Holmium-166 microspheres hepatic radioembolization.
Holmium-166 microspheres hepatic radioembolization.
- Response (RECIST 1.1 Partial plus complete) [ Time Frame: 3 months ]To evaluate efficacy of adjuvant 166Ho-radioembolization (166Ho-RE) after systemic 177Lu-dotatate in a non-comparative phase II study
- Quality of Life (QoL) [ Time Frame: 3 months ]To evaluate QoL using EORTC questionnaire. The impact of treatment on QoL will be compared to tumour response, and other parameters. A questionnaire in the patient's native language will be provided.
- Biodistribution [ Time Frame: 3 months ]To evaluate biodistribution using CT and quantitative SPECT.
- Dosimetry [ Time Frame: 3 months ]To evaluate dosimetry using CT and quantitative SPECT. The imaging protocol after injection of 166Ho-PLLA-MS will consist of a dual isotope fusion SPECT/CT protocol.
- AD Adverse events [ Time Frame: 1 year ]To establish the safety and toxicity profile of treatment with 166Ho-microspheres as an adjuvant treatment after 177Lu-dotatate. This profile will be established using CTCAE (incl. SAE) methodology (CTCAE version 4.03).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02067988
|Contact: Marnix G Lam, MD, PhDemail@example.com|
|Contact: Tjitske Bosma, CRCfirstname.lastname@example.org|
|University Medical Center Utrecht||Recruiting|
|Utrecht, Netherlands, 3584 CX|
|Principal Investigator: Marnix G Lam, MD, PhD|
|Principal Investigator:||Marnix G Lam, MD, PhD||UMC Utrecht, The Netherlands|