Neuroendocrine TumorsNCT04622631
Using 18F- FDG,18F-DOPA and 68Ga-DOTATATE PET/CT in Detection and Evaluation of Response in Patients With NET Undergoing PRRT
An observational study of Neuroendocrine Tumors, run by Dr. Nayruz Knaana at 1 site in Israel.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuroendocrine Tumors
- How many people
- 80 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2020to Jan 2023
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patient with neuroendocrine tumor who were found to be eligible for Peptide Receptor Radionuclide Therapy (PRRT)
Who may be able to join
- patient with neuroendocrine tumor
- eligible for PRRT
Who cannot join
- younger than 18 years old
- pregnancy
Trial locations and contacts
1 site in 1 country.
domachevsky contact
Israel1 site, 1 recruiting
- Recruiting
Sheba Medical Center
Ramat Gan
kanana yassin, 0545680499, nayruz.knaana@sheba.health.gov.il
About this study
Official title: the Use of 18F-FDG, 18F-DOPA and 68Ga-DOTATATE PET/CT in Patients With NETs That Are Potential Candidates for PRRT
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
Read the detailed 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 .
- Conditions
- Neuroendocrine Tumors
- Keywords
- Peptide Receptor Radionuclide treatment
- Medical subject headings
- Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with good response to Peptide Receptor Radionuclide Therapy (PRRT)
patients who have clinical and radiological improvement (using RECIST CRITERIA )
Measured: 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 )
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2020
- Study startNov 2020 (estimated)
- Primary completionJan 2022 (estimated)
- Study completionJan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroendocrine TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Dr. Nayruz Knaana
- Sponsor type
- Other government
- Collaborators
- Sheba Medical Center
- Responsible party
- Sponsor-investigator, Dr. Nayruz Knaana, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04622631
- Sponsor's protocol ID
- SHEBA-20- 6260-NK-CTIL
- Status last verified
- Oct 2020
- First submitted
- 30 Oct 2020
- Last updated
- 10 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Use of 18F-FDG, 18F-DOPA and 68Ga-DOTATATE PET/CT in Patients With NETs That Are Potential Candidates for PRRT
- ClinicalTrials.gov ID
- NCT04622631
- Acronym / sponsor ID
- SHEBA-20- 6260-NK-CTIL
- Conditions
- Neuroendocrine Tumors
- Keywords
- Peptide Receptor Radionuclide treatment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Dr. Nayruz KnaanaOther government
- Collaborators
- Sheba Medical Center
- Study start
- Nov 2020 (estimated)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 10 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed 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 .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patient with neuroendocrine tumor who were found to be eligible for Peptide Receptor Radionuclide Therapy (PRRT)
Key inclusion criteria (2 listed)
- patient with neuroendocrine tumor
- eligible for PRRT
Key exclusion criteria (2 listed)
- younger than 18 years old
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of participants with good response to Peptide Receptor Radionuclide Therapy (PRRT)
Time frame: 7 months
patients who have clinical and radiological improvement (using RECIST CRITERIA )
Number of participants with no response to Peptide Receptor Radionuclide Therapy (PRRT) treatment
Time frame: 7 months
patients who have no clinical and radiological improvement or worsening in clinical condition or radiologic findings (RECIST )
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2020.
Related trials for Neuroendocrine Tumors
RecruitingPhase 2
Lu-177-DOTATATE (Lutathera) in Therapy of Inoperable Pheochromocytoma/ Paraganglioma
Pheochromocytoma, Paraganglioma
Active, not recruitingPhase 3
Testing Cabozantinib in Patients With Advanced Pancreatic Neuroendocrine and Carcinoid Tumors
Functioning Pancreatic Neuroendocrine Tumor, Intermediate Grade Lung Neuroendocrine Neoplasm
RecruitingPhase 2
Testing the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) With One Anti-cancer Targeted Drug (Cabozantinib) for Rare Genitourinary Tumors
Bladder Adenocarcinoma, Bladder Clear Cell Adenocarcinoma
RecruitingPhase 1/2
A Study to Evaluate the Efficacy and Safety of Ifinatamab Deruxtecan (I-DXd) in Subjects With Recurrent or Metastatic Solid Tumors (IDeate-PanTumor02)
Recurrent or Metastatic Solid Tumors
RecruitingPhase 2
A UGT1A1 Genotype-Directed Study of Belinostat Pharmacokinetics and Toxicity
Carcinoma, Neuroendocrine, Tumor, Neuroendocrine
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
domachevsky contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuroendocrine Tumors, run by Dr. Nayruz Knaana at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact kanana yassin (0545680499, nayruz.knaana@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with good response to Peptide Receptor Radionuclide Therapy (PRRT) (time frame: 7 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2020; AzTrials last refreshed its copy on 26 Oct 2026.