NCT04296149

Brief Summary

Radioguided surgery (RGS) with beta- radioisotopes is a novel approach focused on developing a new probe which, detecting electrons and operating with low background, provides a clearer delineation of the margins of lesions with low radiation exposition for surgeons. To validate this procedure, ex vivo specimens of tumours expressing somatostatin receptors, as small-intestine neuroendocrine (SI-NET), will be tested

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Feb 2017

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 16, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 3, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 5, 2020

Completed
Last Updated

March 5, 2020

Status Verified

March 1, 2020

Enrollment Period

1.9 years

First QC Date

March 3, 2020

Last Update Submit

March 3, 2020

Conditions

Neuroendocrine Tumors

Keywords

beta- proberadioguided surgery

Outcome Measures

Primary Outcomes (1)

  • Evaluation of sensitivity of a beta- probe

    after receiving a small amount of radioactivity, patients will be operated and an evaluation of radioactivity on surgical specimens will be evaluated

    2 years

Study Arms (1)

Y-90-DOTATOC

EXPERIMENTAL

Patients affected by Small Intestine neuroendocrine tumors

Drug: Y90-DOTA-Tyr3-Octreotide

Interventions

Y90-DOTA-Tyr3-OctreotideDRUG

Patients enrolled for surgery will receive a small amount of Y-90-DOTATOC, in order to check beta- radioactivity by the probe

Also known as: Beta- emetting radioisotope
Y-90-DOTATOC

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • SI NET patients, Ga-68-DOTATOC PET/CT positive, proposed for surgery

You may not qualify if:

  • negative PET/CT; pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chiara Maria Grana

Milan, 20141, Italy

Location

MeSH Terms

Conditions

Neuroendocrine Tumors

Interventions

90Y-octreotide, DOTA-Tyr(3)-

Condition Hierarchy (Ancestors)

Neuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve Tissue

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2020

First Posted

March 5, 2020

Study Start

February 16, 2017

Primary Completion

December 31, 2018

Study Completion

December 31, 2019

Last Updated

March 5, 2020

Record last verified: 2020-03

Locations

IT(1)