MeningiomaEarly Phase 1NCT03001349
68Ga-DOTA-TOC PET/CT in Imaging Participants With Neuroendocrine Tumors
A Early Phase 1 study testing Computed Tomography, Gallium Ga 68-Edotreotide and Positron Emission Tomography in people with Meningioma and Metastatic Well Differentiated Neuroendocrine Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This trial studies how well gallium Ga 68-edotreotide (68Ga-DOTA-TOC) positron emission tomography (PET)/computer tomography (CT) works in imaging participants with neuroendocrine tumors. 68Ga-DOTA-TOC is used as a tracer chemical during PET/CT scans. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Meningioma, Metastatic Well Differentiated Neuroendocrine Neoplasm, Multiple Endocrine Neoplasia Type 1
- What is being tested?
- Computed Tomography, Gallium Ga 68-Edotreotide and Positron Emission Tomography
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 16 May 2017to 5 Feb 2021
- Phase
- Early Phase 1
- 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
- Ability of the subject, or the 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
- All participants must meet one of the following:
- Patients diagnosed or suspected to have neuroendocrine tumors (NET), who require 111In-pentetreotide imaging for clinical indications
- Subjects with a high risk of NET because of familial predisposition, and also have clinical findings which require radiolabeled somatostatin imaging
- Other somatostatin-positive tumors for which 111In-pentetreotide has been used successfully, such as adult meningiomas
- Patients with suspected neuroendocrine tumor, unknown primary NET, metastatic NET, or other tumors, such as meningiomas, in whom the primary physician considers somatostatin imaging to be clinically indicated
- Other NET subjects, whether asymptomatic or symptomatic, sporadic or familial, such as Von Hippel-Lindau syndrome (VHL) and multiple endocrine neoplasia type 1 (MEN1), will also be included
Who cannot join
- Pregnant women are excluded from this study because the effects of 68Ga-DOTATOC in pregnancy are not known; exceptions may be granted only if the expected risk outweighs the benefit, in the clinical opinion of the attending physician. Pregnancy testing will follow MD Anderson procedure for diagnostic reagents. Self-reporting is used to assess pregnancy status. If the subject is unsure about her status, a urine or serum pregnancy test will be performed before inclusion
- Lactating women are excluded if patient is unwilling to suspend lactation for at least one day following the administration of 68Ga-DOTATOC to the mother, because of the unknown but potential risk for adverse events in nursing infants secondary to administration of the radionuclide to a lactating woman
- Subjects with known contraindications to the use of 111In-pentetreotide
- Known severe allergy or hypersensitivity to oral contrast precludes administration of oral contrast only
- Patients with a body weight of 400 pounds or more, or a body mass index (BMI) which precludes their entry into the bore of the PET/CT scanner, because of the resulting probable compromise in image quality with CT, PET/CT and magnetic resonance imaging (MRI)
- 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.
About this study
Official title: An Expanded Access Imaging of Neuroendocrine Tumors Using 68Ga-DOTA-TOC
This trial studies how well gallium Ga 68-edotreotide (68Ga-DOTA-TOC) positron emission tomography (PET)/computer tomography (CT) works in imaging participants with neuroendocrine tumors. 68Ga-DOTA-TOC is used as a tracer chemical during PET/CT scans. Diagnostic procedures, such as 68Ga-DOTA-TOC PET/CT, may help find and diagnose neuroendocrine tumors.
Read the detailed description
PRIMARY OBJECTIVES:
- To substitute 68Ga-DOTATOC for 111In-pentetreotide on an expanded access basis, in tumor imaging for study subjects, where the care provider believes that somatostatin imaging is clinically indicated, until such time as 68Ga-DOTATOC becomes commercially available.
SECONDARY OBJECTIVES:
- To gain experience in the utility of 68Ga-DOTATOC in the management of neuroendocrine tumors at The University of Texas M.D. Anderson Cancer Center (MDACC).
II. To acquire proficiency in generating 68Ga-DOTATOC for human use at MDACC.
OUTLINE:
Participants receive gallium Ga 68-edotreotide intravenously. After 1 hour, participants undergo PET/CT scan over 60 minutes.
After completion of study, participants are followed up at 24 hours or within 72 hours, and at 30 days.
- Conditions
- Meningioma, Metastatic Well Differentiated Neuroendocrine Neoplasm, Multiple Endocrine Neoplasia Type 1, Neuroendocrine Neoplasm, Somatostatin Positive Neoplastic Cells Present, Von Hippel-Lindau Syndrome
- Being tested
- Computed Tomography, Gallium Ga 68-Edotreotide, Positron Emission Tomography
- Medical subject headings
- Meningioma, Multiple Endocrine Neoplasia Type 1, Neuroendocrine Tumors, von Hippel-Lindau Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computerized Axial Tomography, computerized tomography
Undergo PET/CT
Gallium Ga 68-EdotreotideDrug
Also called 68Ga-DOTA-d-Phe1-Tyr3-octreotide, 68Ga-DOTA-TOC, EDOTREOTIDE GALLIUM GA-68, Ga-68 DOTA0-Tyr3-octreotide
Given IV
Positron Emission TomographyProcedure or surgery
Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan
Undergo PET/CT
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (gallium Ga 68-edotreotide, PET/CT) | Experimental | Participants receive gallium Ga 68-edotreotide intravenously. After 1 hour, participants undergo PET/CT scan over 60 minutes. Receives: Procedure: Computed Tomography; Drug: Gallium Ga 68-Edotreotide; Procedure: Positron Emission Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
As measured by National Cancer Institute Common Terminology Criteria for Adverse Events version 4. Traceable toxicity/safety data will be assessed. Adverse events and vital signs will be monitored and described with descriptive statistics.
Measured: Up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2016 (estimated)
- Study start16 May 2017
- Primary completion5 Feb 2021
- Study completion5 Feb 2021
Why it stopped: Per PI Request
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MeningiomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Homer A Macapinlac, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03001349
- Sponsor's protocol ID
- 2016-0030
- Other IDs
- NCI-2018-01894, 2016-0030
- Status last verified
- Feb 2021
- First submitted
- 20 Dec 2016
- Last updated
- 15 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Expanded Access Imaging of Neuroendocrine Tumors Using 68Ga-DOTA-TOC
- ClinicalTrials.gov ID
- NCT03001349
- Acronym / sponsor ID
- 2016-0030
- Conditions
- Meningioma, Metastatic Well Differentiated Neuroendocrine Neoplasm, Multiple Endocrine Neoplasia Type 1, Neuroendocrine Neoplasm, Somatostatin Positive Neoplastic Cells Present, Von Hippel-Lindau Syndrome
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Per PI Request
- Enrolment
- 4 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 16 May 2017 (actual)
- Primary completion
- 5 Feb 2021 (actual)
- Study completion
- 5 Feb 2021 (actual)
- First posted
- 23 Dec 2016 (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.
This trial studies how well gallium Ga 68-edotreotide (68Ga-DOTA-TOC) positron emission tomography (PET)/computer tomography (CT) works in imaging participants with neuroendocrine tumors. 68Ga-DOTA-TOC is used as a tracer chemical during PET/CT scans. Diagnostic procedures, such as 68Ga-DOTA-TOC PET/CT, may help find and diagnose neuroendocrine tumors.
Detailed description
PRIMARY OBJECTIVES:
- To substitute 68Ga-DOTATOC for 111In-pentetreotide on an expanded access basis, in tumor imaging for study subjects, where the care provider believes that somatostatin imaging is clinically indicated, until such time as 68Ga-DOTATOC becomes commercially available.
SECONDARY OBJECTIVES:
- To gain experience in the utility of 68Ga-DOTATOC in the management of neuroendocrine tumors at The University of Texas M.D. Anderson Cancer Center (MDACC).
II. To acquire proficiency in generating 68Ga-DOTATOC for human use at MDACC.
OUTLINE:
Participants receive gallium Ga 68-edotreotide intravenously. After 1 hour, participants undergo PET/CT scan over 60 minutes.
After completion of study, participants are followed up at 24 hours or within 72 hours, and at 30 days.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (gallium Ga 68-edotreotide, PET/CT) | Experimental | Procedure: Computed Tomography, Drug: Gallium Ga 68-Edotreotide, Procedure: Positron Emission TomographyParticipants receive gallium Ga 68-edotreotide intravenously. After 1 hour, participants undergo PET/CT scan over 60 minutes. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Ability of the subject, or the 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
- All participants must meet one of the following:
Key exclusion criteria (6 listed)
- Pregnant women are excluded from this study because the effects of 68Ga-DOTATOC in pregnancy are not known; exceptions may be granted only if the expected risk outweighs the benefit, in the clinical opinion of the attending physician. Pregnancy testing will follow MD Anderson procedure for diagnostic reagents. Self-reporting is used to assess pregnancy status. If the subject is unsure about her status, a urine or serum pregnancy test will be performed before inclusion
- Lactating women are excluded if patient is unwilling to suspend lactation for at least one day following the administration of 68Ga-DOTATOC to the mother, because of the unknown but potential risk for adverse events in nursing infants secondary to administration of the radionuclide to a lactating woman
- Subjects with known contraindications to the use of 111In-pentetreotide
- Known severe allergy or hypersensitivity to oral contrast precludes administration of oral contrast only
- Patients with a body weight of 400 pounds or more, or a body mass index (BMI) which precludes their entry into the bore of the PET/CT scanner, because of the resulting probable compromise in image quality with CT, PET/CT and magnetic resonance imaging (MRI)
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 |
|---|---|---|
| Computed TomographyAlso: CAT, CAT Scan, Computerized Axial Tomography, computerized tomographyUndergo PET/CT | Procedure or surgery | Diagnostic (gallium Ga 68-edotreotide, PET/CT) |
| Gallium Ga 68-EdotreotideAlso: 68Ga-DOTA-d-Phe1-Tyr3-octreotide, 68Ga-DOTA-TOC, EDOTREOTIDE GALLIUM GA-68, Ga-68 DOTA0-Tyr3-octreotideGiven IV | Drug | Diagnostic (gallium Ga 68-edotreotide, PET/CT) |
| Positron Emission TomographyAlso: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography ScanUndergo PET/CT | Procedure or surgery | Diagnostic (gallium Ga 68-edotreotide, PET/CT) |
Primary outcome
Incidence of adverse events
Time frame: Up to 30 days
As measured by National Cancer Institute Common Terminology Criteria for Adverse Events version 4. Traceable toxicity/safety data will be assessed. Adverse events and vital signs will be monitored and described with descriptive statistics.
Results and safety
The study was stopped early (reason given: Per PI Request). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2021.
- MD Anderson Cancer Center WebsiteLink 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.
Homer A Macapinlac, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Computed Tomography, Gallium Ga 68-Edotreotide and Positron Emission Tomography in people with Meningioma and Metastatic Well Differentiated Neuroendocrine Neoplasm, run by M.D. Anderson 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 7 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: stopped early, as of the sponsor's last update on 15 Feb 2021. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Per PI Request). 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.
What does the primary outcome measure?
Incidence of adverse events (time frame: Up to 30 days). 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 15 Feb 2021.