Neuroendocrine TumorsNCT02358018
68Ga-DOTATOC for Imaging of Neuroendocrine Tumors: Expanded Access Trial
A study testing 68Ga-DOTATOC PET/CT Scan in people with Neuroendocrine Tumors, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to use a new type of scan, called 68Ga-DOTATOC PET/CT scan, instead of OctreoScan, the standard scan, to diagnose, monitor and manage your tumor. 68Ga-DOTATOC is an improved imaging agent being routinely used in many centers outside the USA, with better tumor detection than with OctreoScan. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Neuroendocrine Tumors
- What is being tested?
- 68Ga-DOTATOC PET/CT Scan
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- 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 5 years and older
- All sexes
- Child, Adult, Older adult
Who may be able to join
- Patients diagnosed or suspected NET requiring 111In-pentetreotide imaging for clinical indications.
- High risk of NET because of familial predisposition with clinical findings requiring radiolabeled somatostatin imaging.
- Other somatostatin positive tumor for which 111In-pentetreotide has been used successfully (for example adult meningioma).
- Ability of subject or Legally Authorized Representative (LAR) (if the patient is deemed by the treating physician to be cognitively impaired or questionably impaired in such a way that the ability of the patient to give informed consent is questionable) to understand and the willingness to sign a written informed consent.
Who cannot join
- Pregnant or lactating women: Pregnant women are excluded from this study because the effects of 68Ga-DOTATOC in pregnancy are not known; exceptions may be performed if expected risk outweighs the benefit. Pregnancy testing will follow MITS procedure for diagnostic reagents. Patients self report pregnancy status. If pregnant the test will not be performed unless in the clinical opinion of the attending physician the gain of the test is likely to outweigh the risk (this will be rare). If unsure whether pregnant or not then a urine or serum pregnancy will be performed.
- Because there is an unknown but potential risk for adverse events in nursing infants secondary to administration of 68Ga-DOTATOC in the mother, breastfeeding should be discontinued for at least one day if the mother receives 68Ga-DOTATOC.
- Patients that have contraindications for 111In-pentetreotide.
- Known severe allergy or hypersensitivity to oral contrast will preclude administration of such contrast (will preclude receiving oral contrast only).
- Patients with a body weight of 400 pounds or more or not able to enter the bore of the PET/CT scanner due to BMI, because of the compromise in image quality with CT, PET/CT and MRI that will result.
- Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
The purpose of this study is to use a new type of scan, called 68Ga-DOTATOC PET/CT scan, instead of OctreoScan, the standard scan, to diagnose, monitor and manage your tumor. 68Ga-DOTATOC is an improved imaging agent being routinely used in many centers outside the USA, with better tumor detection than with OctreoScan.
- Conditions
- Neuroendocrine Tumors
- Being tested
- 68Ga-DOTATOC PET/CT Scan
- Keywords
- 68Ga-DOTATOC, PET/CT scan, 14-226
- Medical subject headings
- Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-DOTATOC PET/CT ScanDrug
Study participants will undergo the 68Ga-DOTATOC PET/CT after informed consent. The nominal injected dose will be up 3-5.5 mCi containing approximately 10 - 50 microgram of 68Ga-DOTATOC and will be injected via IV access lines. CT scans will be performed with our standard oral contrast agent (typically Omnipaque and/or barium) in accordance with our standard FDG practice unless some contraindication is present. Uptake period following injection will be 0.75-1hour. Acquisition time will be approximately ~1 hour. In patients who may not be able to lie still, anesthesia will be provided as per routine standard clinical practice.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2015 (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 Memorial Sloan Kettering Cancer CenterThe 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
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ravinder Grewal, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02358018
- Sponsor's protocol ID
- 14-226
- Status last verified
- Nov 2016
- First submitted
- 3 Feb 2015
- Last updated
- 2 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 68Ga-DOTATOC for Imaging of Neuroendocrine Tumors: Expanded Access Trial
- ClinicalTrials.gov ID
- NCT02358018
- Acronym / sponsor ID
- 14-226
- Conditions
- Neuroendocrine Tumors
- Keywords
- 68Ga-DOTATOC, PET/CT scan, 14-226
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- First posted
- 6 Feb 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.
The purpose of this study is to use a new type of scan, called 68Ga-DOTATOC PET/CT scan, instead of OctreoScan, the standard scan, to diagnose, monitor and manage your tumor. 68Ga-DOTATOC is an improved imaging agent being routinely used in many centers outside the USA, with better tumor detection than with OctreoScan.
Study design
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients diagnosed or suspected NET requiring 111In-pentetreotide imaging for clinical indications.
- High risk of NET because of familial predisposition with clinical findings requiring radiolabeled somatostatin imaging.
- Other somatostatin positive tumor for which 111In-pentetreotide has been used successfully (for example adult meningioma).
- Ability of subject or Legally Authorized Representative (LAR) (if the patient is deemed by the treating physician to be cognitively impaired or questionably impaired in such a way that the ability of the patient to give informed consent is questionable) to understand and the willingness to sign a written informed consent.
Key exclusion criteria (6 listed)
- Pregnant or lactating women: Pregnant women are excluded from this study because the effects of 68Ga-DOTATOC in pregnancy are not known; exceptions may be performed if expected risk outweighs the benefit. Pregnancy testing will follow MITS procedure for diagnostic reagents. Patients self report pregnancy status. If pregnant the test will not be performed unless in the clinical opinion of the attending physician the gain of the test is likely to outweigh the risk (this will be rare). If unsure whether pregnant or not then a urine or serum pregnancy will be performed.
- Because there is an unknown but potential risk for adverse events in nursing infants secondary to administration of 68Ga-DOTATOC in the mother, breastfeeding should be discontinued for at least one day if the mother receives 68Ga-DOTATOC.
- Patients that have contraindications for 111In-pentetreotide.
- Known severe allergy or hypersensitivity to oral contrast will preclude administration of such contrast (will preclude receiving oral contrast only).
- Patients with a body weight of 400 pounds or more or not able to enter the bore of the PET/CT scanner due to BMI, because of the compromise in image quality with CT, PET/CT and MRI that will result.
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 |
|---|---|---|
| 68Ga-DOTATOC PET/CT ScanStudy participants will undergo the 68Ga-DOTATOC PET/CT after informed consent. The nominal injected dose will be up 3-5.5 mCi containing approximately 10 - 50 microgram of 68Ga-DOTATOC and will be injected via IV access lines. CT scans will be performed with our standard oral contrast agent (typically Omnipaque and/or barium) in accordance with our standard FDG practice unless some contraindication is present. Uptake period following injection will be 0.75-1hour. Acquisition time will be approximately ~1 hour. In patients who may not be able to lie still, anesthesia will be provided as per routine standard clinical practice. | 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 2 Nov 2016.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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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.
Ravinder Grewal, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 68Ga-DOTATOC PET/CT Scan in people with Neuroendocrine Tumors, run by Memorial Sloan Kettering Cancer Center 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 4 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: status not confirmed, as of the sponsor's last update on 2 Nov 2016. 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?
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 2 Nov 2016.