Neuroendocrine TumorNCT01448083
Heart/Mediastinal Ratio Study for Potential Equivalence of Heart/Mediastinal Ratios at One and Two Hours to the Traditional Heart/Mediastinal Ratio Obtained at Four Hours
An observational study of Neuroendocrine Tumor, run by Nuclear Medicine Consultants, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to determine if the measurement (with a standard nuclear camera) of radioactivity normally present in the nervous system of your heart at four hours after the injection of radioactive drug for your diagnostic I-123 MIBG scan is any different than radioactivity measured in your heart at one… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuroendocrine Tumor
- Type of treatment
- Injection or infusion
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to not given
- Phase
- Observational
- 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
Study population: Neuroendocrine Tumor Clinic
Who may be able to join
- NET patients who are potential candidates for I-131 MIBG therapy, and are having whole body I-123 MIBG scintigraphy as standard of care.
- Male or female patients ≥ 18 years of age.
- Written informed consent from patients obtained in accordance to local guidelines.
- History and physical exam indicating low likelihood, < 10 %, of any significant cardiac disease.
- Echocardiogram within normal limits, including absence of valvular disease and normal LVEF.
- Serum BNP within normal limits. -
Who cannot join
- Patients on drugs which interfere with MIBG uptake - tricyclic antidepressants, phenylpropanolamine, pseudephredine, phenylephrine, sympathomimetics, amphetamines, reserpine, thorazine and thiothixines, calcium channel blockers, cocaine, and long-acting beta blockers.
- >10% likelihood of any significant heart disease, including myocardial ischemia, cardiomyopathies, uncontrolled hypertension, congestive heart failure and valvular heart disease, e.g. see "Likelihood of Assessment of Coronary Artery Disease" below.
- History of uncontrolled diabetes mellitus
- Signs/symptoms of neurological diseases (e.g., Parkinsonian syndromes) or other disease known to affect the sympathetic nervous system.
- Female patients who are pregnant or nursing (lactating), or adults of reproductive potential who are not using effective birth control methods. If there is any question of pregnancy, a serum bHCg will be collected.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Ochsner Medical Center - Kenner
Kenner, Louisiana, 70065
Richard J Campeau, MD
About this study
The purpose of this study is to determine if the measurement (with a standard nuclear camera) of radioactivity normally present in the nervous system of your heart at four hours after the injection of radioactive drug for your diagnostic I-123 MIBG scan is any different than radioactivity measured in your heart at one and/or two hours after your diagnostic scan injection. If equivalent information to the conventional 4 hr H/M ratio could be collected by obtaining H/M ratios at 1 or 2 hour windows, it would greatly facilitate patient acceptance of the procedure since the requirements for obtaining a valid H/M ratio would be considerably less time-consuming.
One hour before being injected with the drug (I-123 MIBG) for your MIBG scan, you will be given a standard dose of non-radioactive iodine (Lugol's solution) to block your thyroid from receiving the small amount of radiation that is a normal part of the MIBG scan. You will then be injected with MIBG, and you will have 10 minute pictures of your chest at 15 minutes, 1 hour, 2 hours, and 4 hours in addition to the standard 24 hour pictures. These pictures will be taken in the Nuclear Medicine Section, Department of Radiology at Ochsner Medical Center-Kenner. The experimental (research) part of this study is having the extra 10-minute pictures of your chest at 15 minutes, 1 hour, 2 hours, and 4 hours. Normally, pictures are only taken 24 hours after the injection. Therefore the research is limited to the four extra pictures taken, and involve no additional injections or I-123 drug beyond that you will be receiving regardless of whether you are part of this research.
- Conditions
- Neuroendocrine Tumor
- Being tested
- Standard of care diagnostic MIBG scan for neuroendocrine tumor diagnosis.
- Keywords
- I-131 MIBG therapy, whole body I-123 MIBG scintigraphy
- Medical subject headings
- Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of care diagnostic MIBG scan for neuroendocrine tumor diagnosis.Other
Each subject will receive a 370 MBq (10 mCi ) (±10%) injection of I- 123 MIBG. Myocardial I-123 MIBG uptake will be quantitatively measured over time via planar imaging acquired at 15 minutes, one, two, four, and at 24 hours (the standard of care time point for NET patient imaging) post I-123MIBG injection.
| Study group | Role | What they receive |
|---|---|---|
| Neuroendocrine tumor patients | Not described Receives: Other: Standard of care diagnostic MIBG scan for neuroendocrine tumor diagnosis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The heart/mediastinal ratio (H/M) at one or two hours post injection of AdreView™ (I-123 MIBG) in neuroendocrine tumor patients is equivalent to the standard 4 hr calculation.
Measured: Approximately 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2011 (estimated)
- Study startOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroendocrine TumorStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nuclear Medicine Consultants, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01448083
- Sponsor's protocol ID
- 11-MIBG-005
- Status last verified
- Sep 2012
- First submitted
- 3 Oct 2011
- Last updated
- 18 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart/Mediastinal Ratio Study for Potential Equivalence of Heart/Mediastinal Ratios at One and Two Hours to the Traditional Heart/Mediastinal Ratio Obtained at Four Hours
- ClinicalTrials.gov ID
- NCT01448083
- Acronym / sponsor ID
- 11-MIBG-005
- Conditions
- Neuroendocrine Tumor
- Keywords
- I-131 MIBG therapy, whole body I-123 MIBG scintigraphy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Nuclear Medicine Consultants, Inc.University, hospital or other
- Study start
- Oct 2011
- First posted
- 7 Oct 2011 (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 determine if the measurement (with a standard nuclear camera) of radioactivity normally present in the nervous system of your heart at four hours after the injection of radioactive drug for your diagnostic I-123 MIBG scan is any different than radioactivity measured in your heart at one and/or two hours after your diagnostic scan injection. If equivalent information to the conventional 4 hr H/M ratio could be collected by obtaining H/M ratios at 1 or 2 hour windows, it would greatly facilitate patient acceptance of the procedure since the requirements for obtaining a valid H/M ratio would be considerably less time-consuming.
One hour before being injected with the drug (I-123 MIBG) for your MIBG scan, you will be given a standard dose of non-radioactive iodine (Lugol's solution) to block your thyroid from receiving the small amount of radiation that is a normal part of the MIBG scan. You will then be injected with MIBG, and you will have 10 minute pictures of your chest at 15 minutes, 1 hour, 2 hours, and 4 hours in addition to the standard 24 hour pictures. These pictures will be taken in the Nuclear Medicine Section, Department of Radiology at Ochsner Medical Center-Kenner. The experimental (research) part of this study is having the extra 10-minute pictures of your chest at 15 minutes, 1 hour, 2 hours, and 4 hours. Normally, pictures are only taken 24 hours after the injection. Therefore the research is limited to the four extra pictures taken, and involve no additional injections or I-123 drug beyond that you will be receiving regardless of whether you are part of this research.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neuroendocrine tumor patients | – | Other: Standard of care diagnostic MIBG scan for neuroendocrine tumor diagnosis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Neuroendocrine Tumor Clinic
Key inclusion criteria (6 listed)
- NET patients who are potential candidates for I-131 MIBG therapy, and are having whole body I-123 MIBG scintigraphy as standard of care.
- Male or female patients ≥ 18 years of age.
- Written informed consent from patients obtained in accordance to local guidelines.
- History and physical exam indicating low likelihood, < 10 %, of any significant cardiac disease.
- Echocardiogram within normal limits, including absence of valvular disease and normal LVEF.
Key exclusion criteria (5 listed)
- Patients on drugs which interfere with MIBG uptake - tricyclic antidepressants, phenylpropanolamine, pseudephredine, phenylephrine, sympathomimetics, amphetamines, reserpine, thorazine and thiothixines, calcium channel blockers, cocaine, and long-acting beta blockers.
- >10% likelihood of any significant heart disease, including myocardial ischemia, cardiomyopathies, uncontrolled hypertension, congestive heart failure and valvular heart disease, e.g. see "Likelihood of Assessment of Coronary Artery Disease" below.
- History of uncontrolled diabetes mellitus
- Signs/symptoms of neurological diseases (e.g., Parkinsonian syndromes) or other disease known to affect the sympathetic nervous system.
- Female patients who are pregnant or nursing (lactating), or adults of reproductive potential who are not using effective birth control methods. If there is any question of pregnancy, a serum bHCg will be collected.
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 |
|---|---|---|
| Standard of care diagnostic MIBG scan for neuroendocrine tumor diagnosis.Each subject will receive a 370 MBq (10 mCi ) (±10%) injection of I- 123 MIBG. Myocardial I-123 MIBG uptake will be quantitatively measured over time via planar imaging acquired at 15 minutes, one, two, four, and at 24 hours (the standard of care time point for NET patient imaging) post I-123MIBG injection. | Other | Neuroendocrine tumor patients |
Primary outcome
The heart/mediastinal ratio (H/M) at one or two hours post injection of AdreView™ (I-123 MIBG) in neuroendocrine tumor patients is equivalent to the standard 4 hr calculation.
Time frame: Approximately 10 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2012.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuroendocrine Tumor, run by Nuclear Medicine Consultants, Inc. 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 6 inclusion and 5 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 18 Sep 2012. 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?
Contact Maria M Chester, RN ((504) 464-8500, mchest@lsuhsc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The heart/mediastinal ratio (H/M) at one or two hours post injection of AdreView™ (I-123 MIBG) in neuroendocrine tumor patients is equivalent to the standard 4 hr calculation. (time frame: Approximately 10 months). 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 18 Sep 2012.