Neuroendocrine TumorsNCT02375464
Gallium-68 DOTATOC for Management of Neuroendocrine Tumors
A study testing Gallium-68 DOTATOC in people with Neuroendocrine Tumors, run by Northwell Health.
Trial summary
Gallium-68 DOTATOC is a material used to find neuroendocrine tumors (NETs) using positron emission tomography (PET scan). The material has already been shown to be better than the currently available imaging agents. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Neuroendocrine Tumors
- What is being tested?
- Gallium-68 DOTATOC
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Apr 2015to Dec 2019
- Phase
- Expanded access
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Proven or suspected neuroendocrine tumor Physician referral for imaging
Who cannot join
- Pregnancy
About this study
Gallium-68 DOTATOC is a material used to find neuroendocrine tumors (NETs) using positron emission tomography (PET scan). The material has already been shown to be better than the currently available imaging agents. This study is designed to evaluate the clinical impact of PET CT scanning using this agent in the evaluation and management of patients with NETs.
Read the detailed description
Patients with NETs will be evaluated by their own physicians. Before doing the PET scan using Gallium-68 DOTATOC, the physicians will be asked to describe the type of treatment that they would recommend. After the test is performed and the result reviewed, the physician will be asked to reevaluate the therapeutic and management options. Data will be analyzed to determine the impact of the testing on patient management.
Gallium-68 has been designated an "orphan drug" due to the relative rarity of NETs. It is expected that the data collected from this and other similar trials will be used to provide data to the FDA regarding the safety and efficacy of this drug as an imaging agent for NETs and ultimately lead to FDA approval.
- Conditions
- Neuroendocrine Tumors
- Being tested
- Gallium-68 DOTATOC
- Keywords
- neuroendocrine tumor, carcinoid tumor
- Medical subject headings
- Neuroendocrine Tumors, Carcinoid Tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gallium-68 DOTATOCDrug
Also called Gallium-68 (DOTA0-Phe1-Tyr3)octreotide
Imaging with Gallium-68 DOTATOC
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2015 (estimated)
- Study startApr 2015
- Primary completionDec 2018 (estimated)
- Study completionDec 2019 (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.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephen Scharf, Northwell Health
- Investigators
- STEPHEN C SCHARF, MD, Principal investigator, Lenox Hill Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02375464
- Sponsor's protocol ID
- 15-0587
- Status last verified
- Nov 2016
- First submitted
- 24 Feb 2015
- Last updated
- 8 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gallium-68 DOTATOC for Management of Neuroendocrine Tumors
- ClinicalTrials.gov ID
- NCT02375464
- Acronym / sponsor ID
- 15-0587
- Conditions
- Neuroendocrine Tumors
- Keywords
- neuroendocrine tumor, carcinoid tumor
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 2 Mar 2015 (estimated)
- 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.
Gallium-68 DOTATOC is a material used to find neuroendocrine tumors (NETs) using positron emission tomography (PET scan). The material has already been shown to be better than the currently available imaging agents. This study is designed to evaluate the clinical impact of PET CT scanning using this agent in the evaluation and management of patients with NETs.
Detailed description
Patients with NETs will be evaluated by their own physicians. Before doing the PET scan using Gallium-68 DOTATOC, the physicians will be asked to describe the type of treatment that they would recommend. After the test is performed and the result reviewed, the physician will be asked to reevaluate the therapeutic and management options. Data will be analyzed to determine the impact of the testing on patient management.
Gallium-68 has been designated an "orphan drug" due to the relative rarity of NETs. It is expected that the data collected from this and other similar trials will be used to provide data to the FDA regarding the safety and efficacy of this drug as an imaging agent for NETs and ultimately lead to FDA approval.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Proven or suspected neuroendocrine tumor Physician referral for imaging
Key exclusion criteria (1 listed)
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gallium-68 DOTATOCAlso: Gallium-68 (DOTA0-Phe1-Tyr3)octreotideImaging with Gallium-68 DOTATOC | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2016.
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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.
STEPHEN C SCHARF, MD principal investigator
Lenox Hill Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Gallium-68 DOTATOC in people with Neuroendocrine Tumors, run by Northwell Health.
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 1 inclusion and 1 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 8 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 8 Nov 2016.