Small Bowel Carcinoid TumorPhase 1NCT03057509
A Pilot Study Of Ga-68-DOTA-TOC Imaging In Participants With Small Bowel Carcinoid Tumors
A Phase 1 study testing Ga-68-DOTA-TOC, Siemens PET/MR scanner and Standard Siemens Software in people with Small Bowel Carcinoid Tumor, run by Massachusetts General Hospital at 2 sites in United States.
Trial summary
This research study is designed to evaluate a type of scan called Ga-68-DOTA-TOC positron emission tomography (PET) scanning as a way of assessing carcinoid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Bowel Carcinoid Tumor
- What is being tested?
- Ga-68-DOTA-TOC, Siemens PET/MR scanner and Standard Siemens Software
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2018to 30 Sep 2021
- Phase
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Have histologically or cytologically confirmed small bowel carcinoid tumor
- Receiving a stable dose of octreotide LAR as a part of a treatment regimen for ≥3months
- Presently planned for ongoing octreotide according to current standard of care for at least 18 months (i.e. throughout the study follow-up period).
- Presently planned for restaging using contrast-enhanced CT scans at baseline and at least every 6 months, as a part of their standard of care assessments.
- The effects of Ga-68-DOTA-TOC on the developing human fetus are unknown. For this reason and because PET imaging agents are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of Ga-68-DOTA-TOC administration.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Participants who have had radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
- Participants with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- History of allergic reactions to IV contrasts or reactions attributed to compounds of similar chemical or biologic composition to Ga-68-DOTA-TOC used in study.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant women are excluded from this study because Ga-68-DOTA-TOC have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to administration of Ga-68-DOTA-TOC to mothers, breastfeeding mothers are also excluded from this study.
- Expected lifespan less than 18 months by investigator assessment
Show all 9Show fewer
- Previous hypersensitivity reaction to LAR octreotide
- Non-removable non-MR compatible placements including hearing aid or dentures, metal IUD, surgical aneurysm clips, cardiac pacemaker, prosthetic heart valve, neurostimulator, implanted pumps, cochlear implants, metal rods, plates or screws, surgery leaving implanted materials, metal injury to eye, metallic tattoos anywhere on the body, tattoos near the eye and transdermal patches
- History of Meniere's disease
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Massachusetts general Hospital
Boston, Massachusetts, 02114
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
This research study is designed to evaluate a type of scan called Ga-68-DOTA-TOC positron emission tomography (PET) scanning as a way of assessing carcinoid tumors.
Read the detailed description
This research study is a Pilot Study, which is the first time investigators are examining this study intervention.
Many patients who are diagnosed with carcinoid tumor undergo treatment with long acting release (LAR) octreotide. It is presently standard for all patients to receive equal doses of octreotide. However, the response to the treatment with the same dose of medication may vary substantially from one person to another. This study uses a novel form of PET/MR imaging to try and better understand how to treat carcinoid tumors, and may in the future allow doctors to tailor treatment dosing based on PET/MR findings and select the right drug dose for an individual person. It is important to note that the participant method of treatment and the dose of the participant medication (Octreotide LAR) will not change in this study.
The imaging technique used in this study is called Ga-68-DOTA-TOC PET/MR scanning. Ga-68-DOTA-TOC is a radioactive tracer that is given by vein to participants before PET scanning. The scanner then detects radioactivity from the tracer that is attached to cells within the body and uses this information to create images (pictures) on a computer screen that can then be analyzed.
These types of scans are investigational. "Investigational", meaning that the scans are still being studied and that research doctors are trying to find out more about them. It also means that the FDA (U.S. Food and Drug Administration) has not approved these types of PET scans for this type of cancer.
- Conditions
- Small Bowel Carcinoid Tumor
- Being tested
- Ga-68-DOTA-TOC, Siemens PET/MR scanner, Standard Siemens Software, LAR Octreotide
- Keywords
- Carcinoid Tumors
- Medical subject headings
- Carcinoid Tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ga-68-DOTA-TOCDrug
Ga-68-DOTA-TOC is a imaging radiotracer that is used for positron emission tomography imaging of a variety of the neuroendocrine tumors. This radiotracer in the body binds to several subtypes of the somatostatin receptor and accumulates in the tissue with high expression of these receptors. Therefore neuroendocrine tumors that express somatostatin receptors can be imaged using this radiotracer.
Siemens PET/MR scannerDevice
Positron emission tomography-magnetic resonance (PET/MR) is a hybrid imaging technology that incorporates magnetic resonance imaging (MRI) soft tissue morphological imaging and positron emission tomography (PET) functional imaging. The Siemens PET/MR system (Biograph mMR) received a CE mark and FDA approval for clinical diagnostic imaging.
Standard Siemens SoftwareOther
The Siemens PET/MR scanner are equipped with a standard clinical visualization software with the advanced application tools based on the Siemens image interpretation engine called syngo.via. This software allows for visualization and interpretation of the image data-sets in the clinical environment.
LAR OctreotideDrug
Also called Sandostatin
LAR octreotide is a man-made protein that is similar to a hormone in the body called somatostatin. LAR Octreotide lowers many substances in the body such as insulin and glucagon, growth hormone, and chemicals that affect digestion. LAR octreotide is used to treat a variety of clinical conditions but most importantly to reduce flushing episodes and watery diarrhea caused by cancerous tumors such as neuroendocrine tumors.
| Study group | Role | What they receive |
|---|---|---|
| Gallium PET/MR Imaging | Experimental | Siemens PET/MR scanner at Martinos Center for Biomedical Imaging will be use.
* Standard Siemens software will be used to perform image analysis and measure parameters such as SUVmean, SUVmax and MTV.
* Standard LAR Octreotide will be administered.
* Ga-68-DOTA-TOC that will be administered prior to PET/MR imaging at 7 days after standard LAR octreotide administration and again at 28 day.
* Ga-68-DOTA-TOC will be administered as a single intravenous dose at a pre-determine dosage. Receives: Drug: Ga-68-DOTA-TOC; Device: Siemens PET/MR scanner; Other: Standard Siemens Software; Drug: LAR Octreotide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in SUVmax
The mean change of SUVmax from 68Ga-DOTATOC PET scan obtained at peak and trough octreotide LAR therapy.
Measured: 2 years
Mean Change in Total Molecular Burden of The Lesions
The mean change of Total Molecular Tumor Burden is measured from 68Ga-DOTATOC PET scan obtained at peak and trough octreotide LAR therapy.
Measured: 2 Years
Secondary outcomes (2)
Correlation Of Change In Receptor Occupancy With The PFS of patients
Measured: 2 years
Progression Free Survival Rate
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2017
- Study startNov 2018 (estimated)
- Primary completion31 Oct 2019 (estimated)
- Study completion30 Sep 2021 (estimated)
Why it stopped: Slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Bowel Carcinoid TumorStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Umar Mahmood, Massachusetts General Hospital
- Investigators
- Umar Mahmood, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03057509
- Sponsor's protocol ID
- 16-193
- Status last verified
- Jun 2019
- First submitted
- 3 Feb 2017
- Last updated
- 21 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Of Ga-68-DOTA-TOC Imaging In Participants With Small Bowel Carcinoid Tumors
- ClinicalTrials.gov ID
- NCT03057509
- Acronym / sponsor ID
- 16-193
- Conditions
- Small Bowel Carcinoid Tumor
- Keywords
- Carcinoid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Slow accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Nov 2018 (estimated)
- Primary completion
- 31 Oct 2019 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 20 Feb 2017 (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.
This research study is designed to evaluate a type of scan called Ga-68-DOTA-TOC positron emission tomography (PET) scanning as a way of assessing carcinoid tumors.
Detailed description
This research study is a Pilot Study, which is the first time investigators are examining this study intervention.
Many patients who are diagnosed with carcinoid tumor undergo treatment with long acting release (LAR) octreotide. It is presently standard for all patients to receive equal doses of octreotide. However, the response to the treatment with the same dose of medication may vary substantially from one person to another. This study uses a novel form of PET/MR imaging to try and better understand how to treat carcinoid tumors, and may in the future allow doctors to tailor treatment dosing based on PET/MR findings and select the right drug dose for an individual person. It is important to note that the participant method of treatment and the dose of the participant medication (Octreotide LAR) will not change in this study.
The imaging technique used in this study is called Ga-68-DOTA-TOC PET/MR scanning. Ga-68-DOTA-TOC is a radioactive tracer that is given by vein to participants before PET scanning. The scanner then detects radioactivity from the tracer that is attached to cells within the body and uses this information to create images (pictures) on a computer screen that can then be analyzed.
These types of scans are investigational. "Investigational", meaning that the scans are still being studied and that research doctors are trying to find out more about them. It also means that the FDA (U.S. Food and Drug Administration) has not approved these types of PET scans for this type of cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gallium PET/MR Imaging | Experimental | Drug: Ga-68-DOTA-TOC, Device: Siemens PET/MR scanner, Other: Standard Siemens Software, Drug: LAR OctreotideSiemens PET/MR scanner at Martinos Center for Biomedical Imaging will be use. * Standard Siemens software will be used to perform image analysis and measure parameters such as SUVmean, SUVmax and MTV. * Standard LAR Octreotide will be administered. * Ga-68-DOTA-TOC that will be administered prior to PET/MR imaging at 7 days after standard LAR octreotide administration and again at 28 day. * Ga-68-DOTA-TOC will be administered as a single intravenous dose at a pre-determine dosage. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years
- Have histologically or cytologically confirmed small bowel carcinoid tumor
- Receiving a stable dose of octreotide LAR as a part of a treatment regimen for ≥3months
- Presently planned for ongoing octreotide according to current standard of care for at least 18 months (i.e. throughout the study follow-up period).
- Presently planned for restaging using contrast-enhanced CT scans at baseline and at least every 6 months, as a part of their standard of care assessments.
Key exclusion criteria (9 listed)
- Participants who have had radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
- Participants with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- History of allergic reactions to IV contrasts or reactions attributed to compounds of similar chemical or biologic composition to Ga-68-DOTA-TOC used in study.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant women are excluded from this study because Ga-68-DOTA-TOC have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to administration of Ga-68-DOTA-TOC to mothers, breastfeeding mothers are also excluded from this study.
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 |
|---|---|---|
| Ga-68-DOTA-TOCGa-68-DOTA-TOC is a imaging radiotracer that is used for positron emission tomography imaging of a variety of the neuroendocrine tumors. This radiotracer in the body binds to several subtypes of the somatostatin receptor and accumulates in the tissue with high expression of these receptors. Therefore neuroendocrine tumors that express somatostatin receptors can be imaged using this radiotracer. | Drug | Gallium PET/MR Imaging |
| Siemens PET/MR scannerPositron emission tomography-magnetic resonance (PET/MR) is a hybrid imaging technology that incorporates magnetic resonance imaging (MRI) soft tissue morphological imaging and positron emission tomography (PET) functional imaging. The Siemens PET/MR system (Biograph mMR) received a CE mark and FDA approval for clinical diagnostic imaging. | Device | Gallium PET/MR Imaging |
| Standard Siemens SoftwareThe Siemens PET/MR scanner are equipped with a standard clinical visualization software with the advanced application tools based on the Siemens image interpretation engine called syngo.via. This software allows for visualization and interpretation of the image data-sets in the clinical environment. | Other | Gallium PET/MR Imaging |
| LAR OctreotideAlso: SandostatinLAR octreotide is a man-made protein that is similar to a hormone in the body called somatostatin. LAR Octreotide lowers many substances in the body such as insulin and glucagon, growth hormone, and chemicals that affect digestion. LAR octreotide is used to treat a variety of clinical conditions but most importantly to reduce flushing episodes and watery diarrhea caused by cancerous tumors such as neuroendocrine tumors. | Drug | Gallium PET/MR Imaging |
Primary outcome
Mean Change in SUVmax
Time frame: 2 years
The mean change of SUVmax from 68Ga-DOTATOC PET scan obtained at peak and trough octreotide LAR therapy.
Mean Change in Total Molecular Burden of The Lesions
Time frame: 2 Years
The mean change of Total Molecular Tumor Burden is measured from 68Ga-DOTATOC PET scan obtained at peak and trough octreotide LAR therapy.
2 secondary outcomes
Correlation Of Change In Receptor Occupancy With The PFS of patients
Time frame: 2 years
Progression Free Survival Rate
Time frame: 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2019.
- Individual participant dataSharing planned: No
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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.
Umar Mahmood, MD, PhD principal investigator
Massachusetts General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ga-68-DOTA-TOC, Siemens PET/MR scanner and Standard Siemens Software in people with Small Bowel Carcinoid Tumor, run by Massachusetts General Hospital at 2 sites 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 9 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: withdrawn, as of the sponsor's last update on 21 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 withdrawn before enrolling participants, so there are no results.
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?
Mean Change in SUVmax (time frame: 2 years). 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 21 Jun 2019.