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NCT04622631 Clinical Trial

Using 18F- FDG,18F-DOPA and 68Ga-DOTATATE PET/CT in Detection and Evaluation of Response in Patients With NET Undergoing PRRT

Neuroendocrine Tumors Clinical Trial

Official title:
the Use of 18F-FDG, 18F-DOPA and 68Ga-DOTATATE PET/CT in Patients With NETs That Are Potential Candidates for PRRT

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04622631
Other study ID # SHEBA-20- 6260-NK-CTIL
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 2020
Est. completion date January 2023

Study information
Verified date October 2020
Source Sheba Medical Center
Contact kanana yassin
Phone 0545680499
Email nayruz.knaana@sheba.health.gov.il
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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

Description:

patients with suspected or biopsy proven NET will undergo imaging using a Combination of 18F- FDG , 18F-DOPA and 68Ga-DOTATATE PET/CT before the stat of PRRT . after two cycles of treatment another two PET/CT are done using 18F- FDG and 18F-DOPA and about 6-8 weeks from last treatment the patient will undergo PET/CT using 18F-DOPA .

Recruitment information / eligibility
Status Recruiting
Enrollment 80
Est. completion date January 2023
Est. primary completion date January 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - patient with neuroendocrine tumor - eligible for PRRT Exclusion Criteria: - younger than 18 years old - pregnancy

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Israel Sheba Medical Center Ramat Gan

Sponsors (2)
Lead Sponsor Collaborator
Dr. Nayruz Knaana Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of participants with good response to Peptide Receptor Radionuclide Therapy (PRRT) patients who have clinical and radiological improvement (using RECIST CRITERIA ) 7 months
Primary 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
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