HealthyPhase 1/2NCT01672996
Open Label, Randomized Study of Low Concentration Ioforminol Injections for Use in Abdominal CECT in Healthy Volunteers
A Phase 1/2 study testing Ioforminol 160 mgI/mL, Ioforminol 200 mgI/mL and Iopamidol 300 mgI/mL in people with Healthy, run by GE Healthcare at 1 site in United States.
Trial summary
To optimize both the Ioforminol concentration and dosage(s) for CECT of the abdomen. To evaluate the safety and tolerability of low concentration Ioforminol Injections. Study recruits healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Ioforminol 160 mgI/mL, Ioforminol 200 mgI/mL and Iopamidol 300 mgI/mL
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Aug 2012
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males or females between 18 and 50 years of age.
- The subject has a maximum abdominal circumference of 120 cm or less.
Who cannot join
- The subject has known Grade 3 or 4 allergic reaction/hypersensitivity to either iodine or any iodinated-based contrast agent or with history of multiple allergies (i.e., foods, pets, medications, etc).
- The subject has chronic renal insufficiency (estimated glomerular filtration rate [eGFR] <60 mg/dL) as measured at the screening visit.
- The subject is pregnant or breast-feeding.
- The subject has suspicion or diagnosis of hyperthyroidism or autonomously functioning thyroid nodule confirmed by T3, T4, and/or thyroid-stimulating hormone.
- The subject has severe liver or hematologic diseases (sickle cell disease or multiple myeloma), or immunodeficiency.
- The subject is taking metformin (e.g., Glucophage®) therapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1/2, Open Label, Randomized Study of Low Concentration Ioforminol Injections for Use in Contrast-Enhanced Abdominal Computed Tomography in Healthy Volunteers
To optimize both the Ioforminol concentration and dosage(s) for CECT of the abdomen. To evaluate the safety and tolerability of low concentration Ioforminol Injections. Study recruits healthy volunteers.
- Conditions
- Healthy
- Being tested
- Ioforminol 160 mgI/mL, Ioforminol 200 mgI/mL, Iopamidol 300 mgI/mL
- Keywords
- Use in Abdominal, Contrast Enhanced, Computed Tomography, Optimize concentration, dosage of Ioforminol Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ioforminol 160 mgI/mLDrug
Also called Ioforminol
Given as s single administration to the subject
Ioforminol 200 mgI/mLDrug
Also called Ioforminol
Given as a single administration to the subject
Iopamidol 300 mgI/mLDrug
Also called Iopamidol, Isovue 300, Isovue
Given as a single administration to the subject
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 - Ioforminol 160mgI/mL | Experimental | Single administration of Ioforminol 160mgI/mL given to the subject. Receives: Drug: Ioforminol 160 mgI/mL |
| Arm 2 - Ioforminol 200mgI/mL | Experimental | Given as a single administration to the subject Receives: Drug: Ioforminol 200 mgI/mL |
| Arm 3 - Iopamidol 300mgI/mL | Active comparator | Given as a single administration to the subject Receives: Drug: Iopamidol 300 mgI/mL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic Densities at Selected Regions in Contrast-enhanced CT Examination by Location (Abdominal Aorta), kVp 80 and Contrast Type (Ioforminol vs Iopamidol), Concentration (Ioforminol 160 or 200) and Dose Levels (1.0, 1.5, and 2.0mL/kg).
Quantitative measurement of the radiographic density (as measured by Hounsfield Units (HU) ) at the abdominal aorta at the level of the celiac artery. The greater the contrast attenuation, the higher the HU.
Measured: Within 5 minutes after administration for either Ioforminol or Iopamidol.
Radiographic Densities at Selected Regions in Contrast-enhanced CT Examination by Location (Abdominal Aorta), kVp 100 and Contrast Type (Ioforminol vs Iopamidol), Concentration (Ioforminol 160 or 200) and Dose Levels (1.0, 1.5, and 2.0mL/kg).
Quantitative measurement of the radiographic density (as measured by Hounsfield Units (HU) ) at the abdominal aorta at the level of the celiac artery. The greater the contrast attenuation, the higher the HU.
Measured: Within 5 minutes after administration for either Ioforminol or Iopamidol.
Secondary outcomes (1)
Evaluate the Overall Safety of Ioforminol and Iopamidol Injections by Recording Treatment Emergent Adverse Events (TEAE).
Recording the occurrence of treatment emergent adverse events (TEAE).
Measured: Up to 72 hours for safety monitoring post Ioforminol and Iopamidol administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2012 (estimated)
- Study startJul 2012
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by GE HealthcareThe 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 1/2
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- GE Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Physician Reference Laboratory, Quintiles, Inc.
- Responsible party
- Sponsor
- Investigators
- Rubin Sheng, MD, Study director, GE Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01672996
- Sponsor's protocol ID
- GE-145-004
- Status last verified
- Apr 2014
- First submitted
- 9 Aug 2012
- Last updated
- 29 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2, Open Label, Randomized Study of Low Concentration Ioforminol Injections for Use in Contrast-Enhanced Abdominal Computed Tomography in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01672996
- Acronym / sponsor ID
- GE-145-004
- Conditions
- Healthy
- Keywords
- Use in Abdominal, Contrast Enhanced, Computed Tomography, Optimize concentration, dosage of Ioforminol Injection
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- GE HealthcareIndustry (pharma, biotech, devices)
- Collaborators
- Physician Reference Laboratory, Quintiles, Inc.
- Study start
- Jul 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 27 Aug 2012 (estimated)
- Results
- Posted 3 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To optimize both the Ioforminol concentration and dosage(s) for CECT of the abdomen. To evaluate the safety and tolerability of low concentration Ioforminol Injections. Study recruits healthy volunteers.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 - Ioforminol 160mgI/mL | Experimental | Drug: Ioforminol 160 mgI/mLSingle administration of Ioforminol 160mgI/mL given to the subject. |
| Arm 2 - Ioforminol 200mgI/mL | Experimental | Drug: Ioforminol 200 mgI/mLGiven as a single administration to the subject |
| Arm 3 - Iopamidol 300mgI/mL | Active comparator | Drug: Iopamidol 300 mgI/mLGiven as a single administration to the subject |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy males or females between 18 and 50 years of age.
- The subject has a maximum abdominal circumference of 120 cm or less.
Key exclusion criteria (6 listed)
- The subject has known Grade 3 or 4 allergic reaction/hypersensitivity to either iodine or any iodinated-based contrast agent or with history of multiple allergies (i.e., foods, pets, medications, etc).
- The subject has chronic renal insufficiency (estimated glomerular filtration rate [eGFR] <60 mg/dL) as measured at the screening visit.
- The subject is pregnant or breast-feeding.
- The subject has suspicion or diagnosis of hyperthyroidism or autonomously functioning thyroid nodule confirmed by T3, T4, and/or thyroid-stimulating hormone.
- The subject has severe liver or hematologic diseases (sickle cell disease or multiple myeloma), or immunodeficiency.
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 |
|---|---|---|
| Ioforminol 160 mgI/mLAlso: IoforminolGiven as s single administration to the subject | Drug | Arm 1 - Ioforminol 160mgI/mL |
| Ioforminol 200 mgI/mLAlso: IoforminolGiven as a single administration to the subject | Drug | Arm 2 - Ioforminol 200mgI/mL |
| Iopamidol 300 mgI/mLAlso: Iopamidol, Isovue 300, IsovueGiven as a single administration to the subject | Drug | Arm 3 - Iopamidol 300mgI/mL |
Primary outcome
Radiographic Densities at Selected Regions in Contrast-enhanced CT Examination by Location (Abdominal Aorta), kVp 80 and Contrast Type (Ioforminol vs Iopamidol), Concentration (Ioforminol 160 or 200) and Dose Levels (1.0, 1.5, and 2.0mL/kg).
Time frame: Within 5 minutes after administration for either Ioforminol or Iopamidol.
Quantitative measurement of the radiographic density (as measured by Hounsfield Units (HU) ) at the abdominal aorta at the level of the celiac artery. The greater the contrast attenuation, the higher the HU.
Radiographic Densities at Selected Regions in Contrast-enhanced CT Examination by Location (Abdominal Aorta), kVp 100 and Contrast Type (Ioforminol vs Iopamidol), Concentration (Ioforminol 160 or 200) and Dose Levels (1.0, 1.5, and 2.0mL/kg).
Time frame: Within 5 minutes after administration for either Ioforminol or Iopamidol.
Quantitative measurement of the radiographic density (as measured by Hounsfield Units (HU) ) at the abdominal aorta at the level of the celiac artery. The greater the contrast attenuation, the higher the HU.
1 secondary outcome
Evaluate the Overall Safety of Ioforminol and Iopamidol Injections by Recording Treatment Emergent Adverse Events (TEAE).
Time frame: Up to 72 hours for safety monitoring post Ioforminol and Iopamidol administration.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Healthy
Not yet recruitingPhase 2
Investigating the Analgesic Potential of (2R,6R)-HNK in Acute Pain in Healthy Volunteers
Healthy Volunteers
RecruitingObservational study
Collection and Analysis of Blood, Bone Marrow, and Buccal Mucosa Samples From Healthy Volunteers
Healthy Volunteers
RecruitingPhase 1
Bioequivalence Study Between YHP2508A and YHR2601 in Healthy Subjects
Healthy Subjects (HS)
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
RecruitingObservational study
Relationship Between Great Toe Strength And Symptoms of Chemotherapy-Induced Peripheral Neuropathy (CIPN)
Chemotherapy-induced Peripheral Neuropathy (CIPN), Healthy
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.
Rubin Sheng, MD study director
GE Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Ioforminol 160 mgI/mL, Ioforminol 200 mgI/mL and Iopamidol 300 mgI/mL in people with Healthy, run by GE Healthcare 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 29 May 2014. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Radiographic Densities at Selected Regions in Contrast-enhanced CT Examination by Location (Abdominal Aorta), kVp 80 and Contrast Type (Ioforminol vs Iopamidol), Concentration (Ioforminol 160 or 200) and Dose Levels (1.0, 1.5, and 2.0mL/kg). (time frame: Within 5 minutes after administration for either Ioforminol or Iopamidol.). 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 29 May 2014.