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Doxorubicin Eluting Intra-arterial Embolization for Aggressive Desmoid Fibromatosis

NCT03966742 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2022-03-25

No results posted yet for this study

Summary

In this study Drug-eluting microbeads (DEB) loaded with Doxorubicin will be delivered into the target Desmoid Fibromatoses (DF) tissue via selective arterial embolization by angiographic technique. The objective of the study is to demonstrate the safety and efficacy of this treatment.

Conditions

  • Desmoid
  • Desmoid Fibromatosis of Skin
  • Desmoid Neoplasm of Chest Wall
  • Desmoid Tumor Caused by Somatic Mutation
  • Aggressive Fibromatoses
  • Fibromatosis Desmoid
  • Desmoid Fibromatosis

Interventions

PROCEDURE

Drug Eluting Bead Embolization (DEB) for Desmoid Fibromatosis

Delivery of Doxorubicin selectively into Desmoid Fibromatosis utilizing its vascular supply as a conduit, and ionic loading the doxorubicin onto embolized particles as the drug delivery vehicle. Maximal dose is 75 mg/m2 and at least 50 mg. The bead size is 75-300 Mµ in a 2 CC syringe.

Sponsors & Collaborators

  • Rabin Medical Center

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-11
Primary Completion
2020-12-18
Completion
2020-12-18

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03966742 on ClinicalTrials.gov