NCT04622631

Brief Summary

the investigators will follow up after patients with neuroendocrine tumors who undergo PRRT treatment and evaluate the response for treatment using PET/CT with different tracers

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

October 30, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

November 1, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 10, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

November 10, 2020

Status Verified

October 1, 2020

Enrollment Period

1.2 years

First QC Date

October 30, 2020

Last Update Submit

November 9, 2020

Conditions

Neuroendocrine Tumors

Keywords

Peptide Receptor Radionuclide treatment

Outcome Measures

Primary Outcomes (2)

  • Number of participants with good response to Peptide Receptor Radionuclide Therapy (PRRT)

    patients who have clinical and radiological improvement (using RECIST CRITERIA )

    7 months

  • Number of participants with no response to Peptide Receptor Radionuclide Therapy (PRRT) treatment

    patients who have no clinical and radiological improvement or worsening in clinical condition or radiologic findings (RECIST )

    7 months

Study Arms (2)

PRRT positive

patients who have good response to prrt treatment - the tumor and/or the metastatic disease show no uptake/activity on PET-CT scans

PRRT negative

no response to PRRT treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patient with neuroendocrine tumor who were found to be eligible for Peptide Receptor Radionuclide Therapy (PRRT)

You may qualify if:

  • patient with neuroendocrine tumor
  • eligible for PRRT

You may not qualify if:

  • younger than 18 years old
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba Medical Center

Ramat Gan, Israel

RECRUITING

MeSH Terms

Conditions

Neuroendocrine Tumors

Condition Hierarchy (Ancestors)

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

Central Study Contacts

kanana yassin

CONTACT

0545680499nayruz.knaana@sheba.health.gov.il

domachevsky

CONTACT

Liran.Domachevsky@sheba.health.gov.il

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

October 30, 2020

First Posted

November 10, 2020

Study Start

November 1, 2020

Primary Completion

January 1, 2022

Study Completion

January 1, 2023

Last Updated

November 10, 2020

Record last verified: 2020-10

Locations

IL(1)