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A Phase 1 Study of PV-10 Chemoablation of Neuroendocrine Tumours (NET) Metastatic to the Liver

NCT02693067 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2023-02-08

No results posted yet for this study

Summary

This study is intended to determine the safety, tolerability and reduction of biochemical markers (Chromogranin A or, if deemed appropriate, 5-hydroxyindoleaceticacid) and troublesome symptoms (particularly diarrhea and flushing) of intralesional injection of PV-10 in subjects with NET metastatic to the liver that are not amenable to resection or other potentially curative therapy.

Conditions

  • Neuroendocrine Tumors Metastatic to the Liver

Interventions

DRUG

Rose bengal disodium

Percutaneous intralesional injection to NET tumor

Sponsors & Collaborators

  • Provectus Biopharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Eric Wachter, Ph.D. · Provectus Biopharmaceuticals, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2021-09-01
Completion
2023-09-30

Countries

  • Australia

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 NCT02693067 on ClinicalTrials.gov