Neuroendocrine TumorsNCT02539433
Imaging of Neuroendocrine Tumors With PET and Fluoro-18-DOPA (F-DOPA)
A study testing F-18-F-DOPA in people with Neuroendocrine Tumors, run by Northwell Health at 1 site in United States.
Trial summary
Imaging of neuroendocrine (NETs), such as carcinoids and pheochromocytomas (PHEOs), is suboptimal, limiting curative treatment. The investigators wanted to explore the use of PET and F-DOPA i.v. for the localization of these types of neoplasms. Read more about this study
- Who is it for?
- Ages 23 to 81 years
- Conditions the study is for
- Neuroendocrine Tumors
- What is being tested?
- F-18-F-DOPA
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2003to May 2015
- Phase
- Interventional
- 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 23 to 81 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 23 years of age and older
- Appropriate diagnosis by referring physician
Who cannot join
- Less than 23 years of age
- Greater than 81 years of age
- Pregnancy
- Lactation
- Prior history of radiation treatment
- Chemotherapy or anti-tuberculosis medications.
Trial locations and contacts
1 site in 1 country.
United States1 site
North Shore University Hospital
Manhasset, New York, 11030
About this study
Imaging of neuroendocrine (NETs), such as carcinoids and pheochromocytomas (PHEOs), is suboptimal, limiting curative treatment. The investigators wanted to explore the use of PET and F-DOPA i.v. for the localization of these types of neoplasms. The investigators used a similar protocol as they had used for PET (Positron emission tomography) or FDG (Fludeoxyglucose) imaging in oncologic patients. F-DOPA, prepared according to United States Pharmacopeia (USP) guidelines, was approved by the North Shore University Hospital Radiation Safety Committee in 1989 and 1994 for the study of neurological diseases and used uneventfully.
Read the detailed description
Background: Pre surgical conventional imaging of neuroendocrine tumors (NETs) with CT, MRI, In-111 octreotide or 1-123-MIBG (metaiodobenzylguanidine) scintigraphy has limitations. This pilot study tried to improve the localization of these tumors with F-18-F-DOPA PET scanning.
Methods: The investigators studied 22 patients, the majority referred with clinical diagnosis of carcinoid (9) or NETs (9) and a few with pheochromocytoma/paraganglioma (3). Carbidopa was administered prior to the F-DOPA injection in 12 patients. Comparison was made with prior conventional imaging. The F-DOPA findings, read blindly to the findings of other modalities, were compared with results of subsequent surgery (2), endoscopy (1), or a long-term follow up of mean duration of 49 months (for 20 patients). Two subjects were lost to follow-up.
- Conditions
- Neuroendocrine Tumors
- Being tested
- F-18-F-DOPA
- Medical subject headings
- Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
F-18-F-DOPAProcedure or surgery
Also called F-18 fluorodopa
F-18-F-DOPA i.v. injection of a dose of up to 8.5 mCi. PET scanning started 60-90 minutes post injection
| Study group | Role | What they receive |
|---|---|---|
| F-18-F-DOPA i.v. | Experimental | F-18-F-DOPA i.v. one injection of a dose of up to 8.5 mCi (millicurie). Standard PET scanning started 60-90 minutes post injection. Receives: Procedure: F-18-F-DOPA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Imaging of Neuroendocrine Tumors
The investigators expect F-18-DOPA to be taken substantially by carcinoid or pheochromocytoma. The outcome for the study is to identify the location of the neoplasm(s) and compare this data with the clinical OctreoScan or I-131 MIBG performed. If the PET/DOPA scan shows different information than the clinical scan that will be communicated to the referring physician. Efforts will be made to collect information regarding the clinical outcome of the patient, further anatomical imaging and/or surgical pathology results.
Measured: Mean duration 49 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2015 (estimated)
- Study startDec 2003
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Josephine Rini, Northwell Health
- Investigators
- Josephine Rini, MD, Principal investigator, North Shore University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02539433
- Sponsor's protocol ID
- IRB #03-117
- Status last verified
- Aug 2015
- First submitted
- 4 Jun 2015
- Last updated
- 3 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Neuroendocrinology 2006;83:27-64 DOI: 10.1159/000093339 Published online: May 15, 2006 3rd Annual ENETS Conference March 22-24, 2006, Prague, Czech Republic. Imaging of Neuroendocrine Tumors Zanzi I., Warner R.R.P., Babchyck B., Studentsova Y., Bjelke D., Belakhlef A., Margouleff D., Chaly T. North Shore University Hospital, Manhasset, New York University School of Medicine, New York, N.Y., USA
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging of Neuroendocrine Tumors With PET and Fluoro-18-DOPA (F-DOPA)
- ClinicalTrials.gov ID
- NCT02539433
- Acronym / sponsor ID
- IRB #03-117
- Conditions
- Neuroendocrine Tumors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- Dec 2003
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 3 Sep 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.
Imaging of neuroendocrine (NETs), such as carcinoids and pheochromocytomas (PHEOs), is suboptimal, limiting curative treatment. The investigators wanted to explore the use of PET and F-DOPA i.v. for the localization of these types of neoplasms. The investigators used a similar protocol as they had used for PET (Positron emission tomography) or FDG (Fludeoxyglucose) imaging in oncologic patients. F-DOPA, prepared according to United States Pharmacopeia (USP) guidelines, was approved by the North Shore University Hospital Radiation Safety Committee in 1989 and 1994 for the study of neurological diseases and used uneventfully.
Detailed description
Background: Pre surgical conventional imaging of neuroendocrine tumors (NETs) with CT, MRI, In-111 octreotide or 1-123-MIBG (metaiodobenzylguanidine) scintigraphy has limitations. This pilot study tried to improve the localization of these tumors with F-18-F-DOPA PET scanning.
Methods: The investigators studied 22 patients, the majority referred with clinical diagnosis of carcinoid (9) or NETs (9) and a few with pheochromocytoma/paraganglioma (3). Carbidopa was administered prior to the F-DOPA injection in 12 patients. Comparison was made with prior conventional imaging. The F-DOPA findings, read blindly to the findings of other modalities, were compared with results of subsequent surgery (2), endoscopy (1), or a long-term follow up of mean duration of 49 months (for 20 patients). Two subjects were lost to follow-up.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| F-18-F-DOPA i.v. | Experimental | Procedure: F-18-F-DOPAF-18-F-DOPA i.v. one injection of a dose of up to 8.5 mCi (millicurie). Standard PET scanning started 60-90 minutes post injection. |
Who may qualify
- Ages
- 23 to 81 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
Key exclusion criteria (6 listed)
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 |
|---|---|---|
| F-18-F-DOPAAlso: F-18 fluorodopaF-18-F-DOPA i.v. injection of a dose of up to 8.5 mCi. PET scanning started 60-90 minutes post injection | Procedure or surgery | F-18-F-DOPA i.v. |
Primary outcome
Imaging of Neuroendocrine Tumors
Time frame: Mean duration 49 months
The investigators expect F-18-DOPA to be taken substantially by carcinoid or pheochromocytoma. The outcome for the study is to identify the location of the neoplasm(s) and compare this data with the clinical OctreoScan or I-131 MIBG performed. If the PET/DOPA scan shows different information than the clinical scan that will be communicated to the referring physician. Efforts will be made to collect information regarding the clinical outcome of the patient, further anatomical imaging and/or surgical pathology results.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2015.
- Results publicationNeuroendocrinology 2006;83:27-64 DOI: 10.1159/000093339 Published online: May 15, 2006 3rd Annual ENETS Conference March 22-24, 2006, Prague, Czech Republic. Imaging of Neuroendocrine Tumors Zanzi I., Warner R.R.P., Babchyck B., Studentsova Y., Bjelke D., Belakhlef A., Margouleff D., Chaly T. North Shore University Hospital, Manhasset, New York University School of Medicine, New York, N.Y., USA
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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.
Josephine Rini, MD principal investigator
North Shore University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing F-18-F-DOPA in people with Neuroendocrine Tumors, run by Northwell Health at 1 site in United States.
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 6 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: finished, as of the sponsor's last update on 3 Sep 2015. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
Imaging of Neuroendocrine Tumors (time frame: Mean duration 49 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02539433, which also lists 1 linked publication.
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 3 Sep 2015.