Contrast Media AllergyPhase 4NCT02163005
A Feasibility Study to Assess the Use of Gadolinium in Computed Tomography
A Phase 4 study testing Gadolinium in people with Contrast Media Allergy, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Patients with an allergy to iodine based intravenous contrast cannot undergo a CT scan with contrast, unless they are premedicated. Premedication can result in a delay in diagnosis, that can be significant with acute conditions such as Pulmonary embolism. Read more about this study
- Who is it for?
- Ages 56 years and older
- Conditions the study is for
- Contrast Media Allergy
- What is being tested?
- Gadolinium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2016to Dec 2018
- Phase
- Phase 4
- 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 56 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients required to undergo a clinically indicated CT examination
Who cannot join
- subject less than 56 yrs of age
- pregnant women
- Non English speaking
- Abnormal Renal function
- Allergy to Gadolinium
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Gadolinium Enhanced Dual-Energy Computed Tomography: A Feasibility Study to Assess Image Quality and Diagnostic Confidence
Patients with an allergy to iodine based intravenous contrast cannot undergo a CT scan with contrast, unless they are premedicated. Premedication can result in a delay in diagnosis, that can be significant with acute conditions such as Pulmonary embolism.
The investigators are evaluating the use of Gadolinium as an alternative contrast agent in CT. Gadolinium has been used extensively in MRI exams but the dose that is used is not sufficient to provide good enhancement on CT. Dual Energy CT is a new technology that has better sensitivity to lower doses of intravenous contrast and the investigators aim to study its effectiveness in improving the enhancement with Gadolinium. The investigators will compare enhancement of Iodine with enhancement of Gadolinium during Dual Energy CT, to assess the possibility that Gadolinium could be used as an alternative for patients who are suspected of having Pulmonary embolism. They will recruit up to 50 patients who are having a routine Chest CT during treatment for a malignancy and administer Gadolinium contrast and Iodine contrast during a chest CT exam. The enhancement with the two agents can be compared.
Read the detailed description
Although safe in most patients, iodine may be associated with lifethreatening adverse events, particularly in high-risk patient. This application is of particular clinical significance in patients with conditions like pulmonary embolism which could be fatal. CT pulmonary angiogram (CTPA) with sensitivity of 83-100% and specificity of 89-97% is currently the gold standard for diagnosis of pulmonary embolism. However, in patients who have allergy to iodinated contrast agent, CTPA cannot be performed. Gadolinium based contrast agent can serve as a viable alternative in such patients and can be used for Gadolinium enhanced MR pulmonary angiography (MRPA) and CTPA. Gadolinium enhanced MRPA however has inherent limitations in evaluating pulmonary embolism as evident from multicentre prospective study (PIOPED III) which reported technically inadequate exams in as many as 25% of patients (range 11% to 52%). The MRPA sensitivity was also low in the range of 78%. Moreover, unlike CT, low spatial and temporal resolution of MR hampers precise evaluation of lung parenchyma. Previously investigators have evaluated gadolinium enhanced CTPA on a single energy CT (SECT) at different tube potential (80 - 120 kV) and reported encouraging results. However, these patients received higher volume of gadolinium contrast (mean 53 ml, range 30-64 ml) and in spite, the scans performed at 120 kV demonstrated overall suboptimal pulmonary artery enhancement. These limitations can be potentially over come with dual-energy CT which simultaneously acquires low and high energy data. From this data, monochromatic images can be reconstructed at any desired energy from 40 keV to 140 keV.
The investigators aim to recruit up to 50 patients who will guide in determining gadolinium contrast volume, injection rate and image delay required to maximize pulmonary arterial enhancement.
- Conditions
- Contrast Media Allergy
- Being tested
- Gadolinium
- Keywords
- GDL contrast agent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GadoliniumDrug
Also called Dotarem
-agent will be administered intravenously and a CT scan will be performed to evaluate contrast enhancement characteristics of the agent to assess its feasibility as an alternative to Iodine based contrast agents.
| Study group | Role | What they receive |
|---|---|---|
| Gadolinium enhancement | Experimental | Gadolinium enhancement will be performed using intravenous Dotarem[recommended dose of 0.2 mL/kg (0.1 mmol Gd/kg )] Receives: Drug: Gadolinium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vessel enhancement
Following injection of Gadolinium based intravenous contrast, a CT scan will be performed and the level of enhancement of vessels by Gadolinium based contrast will be measured
Measured: Within 1 hour of contrast administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2014 (estimated)
- Study startDec 2016
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Why it stopped: No patients enrolled as study did not move to enrollment stage
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contrast Media AllergyStudies 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 4
- Primary purpose
- Diagnosis
- 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, Amita Sharma, MD, Massachusetts General Hospital
- Investigators
- Amita Sharma, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02163005
- Sponsor's protocol ID
- 2012P002535a
- Status last verified
- Apr 2021
- First submitted
- 11 Jun 2014
- Last updated
- 4 May 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gadolinium Enhanced Dual-Energy Computed Tomography: A Feasibility Study to Assess Image Quality and Diagnostic Confidence
- ClinicalTrials.gov ID
- NCT02163005
- Acronym / sponsor ID
- 2012P002535a
- Conditions
- Contrast Media Allergy
- Keywords
- GDL contrast agent
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No patients enrolled as study did not move to enrollment stage
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 13 Jun 2014 (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.
Patients with an allergy to iodine based intravenous contrast cannot undergo a CT scan with contrast, unless they are premedicated. Premedication can result in a delay in diagnosis, that can be significant with acute conditions such as Pulmonary embolism.
The investigators are evaluating the use of Gadolinium as an alternative contrast agent in CT. Gadolinium has been used extensively in MRI exams but the dose that is used is not sufficient to provide good enhancement on CT. Dual Energy CT is a new technology that has better sensitivity to lower doses of intravenous contrast and the investigators aim to study its effectiveness in improving the enhancement with Gadolinium. The investigators will compare enhancement of Iodine with enhancement of Gadolinium during Dual Energy CT, to assess the possibility that Gadolinium could be used as an alternative for patients who are suspected of having Pulmonary embolism. They will recruit up to 50 patients who are having a routine Chest CT during treatment for a malignancy and administer Gadolinium contrast and Iodine contrast during a chest CT exam. The enhancement with the two agents can be compared.
Detailed description
Although safe in most patients, iodine may be associated with lifethreatening adverse events, particularly in high-risk patient. This application is of particular clinical significance in patients with conditions like pulmonary embolism which could be fatal. CT pulmonary angiogram (CTPA) with sensitivity of 83-100% and specificity of 89-97% is currently the gold standard for diagnosis of pulmonary embolism. However, in patients who have allergy to iodinated contrast agent, CTPA cannot be performed. Gadolinium based contrast agent can serve as a viable alternative in such patients and can be used for Gadolinium enhanced MR pulmonary angiography (MRPA) and CTPA. Gadolinium enhanced MRPA however has inherent limitations in evaluating pulmonary embolism as evident from multicentre prospective study (PIOPED III) which reported technically inadequate exams in as many as 25% of patients (range 11% to 52%). The MRPA sensitivity was also low in the range of 78%. Moreover, unlike CT, low spatial and temporal resolution of MR hampers precise evaluation of lung parenchyma. Previously investigators have evaluated gadolinium enhanced CTPA on a single energy CT (SECT) at different tube potential (80 - 120 kV) and reported encouraging results. However, these patients received higher volume of gadolinium contrast (mean 53 ml, range 30-64 ml) and in spite, the scans performed at 120 kV demonstrated overall suboptimal pulmonary artery enhancement. These limitations can be potentially over come with dual-energy CT which simultaneously acquires low and high energy data. From this data, monochromatic images can be reconstructed at any desired energy from 40 keV to 140 keV.
The investigators aim to recruit up to 50 patients who will guide in determining gadolinium contrast volume, injection rate and image delay required to maximize pulmonary arterial enhancement.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gadolinium enhancement | Experimental | Drug: GadoliniumGadolinium enhancement will be performed using intravenous Dotarem[recommended dose of 0.2 mL/kg (0.1 mmol Gd/kg )] |
Who may qualify
- Ages
- 56 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients required to undergo a clinically indicated CT examination
Key exclusion criteria (5 listed)
- subject less than 56 yrs of age
- pregnant women
- Non English speaking
- Abnormal Renal function
- Allergy to Gadolinium
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 |
|---|---|---|
| GadoliniumAlso: Dotarem-agent will be administered intravenously and a CT scan will be performed to evaluate contrast enhancement characteristics of the agent to assess its feasibility as an alternative to Iodine based contrast agents. | Drug | Gadolinium enhancement |
Primary outcome
Vessel enhancement
Time frame: Within 1 hour of contrast administration
Following injection of Gadolinium based intravenous contrast, a CT scan will be performed and the level of enhancement of vessels by Gadolinium based contrast will be measured
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 4 May 2021.
Related trials for Contrast Media Allergy
Not yet recruitingObservational study
Persistence of Sensitization to Contrast Media
Contrast Media Allergy
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.
Amita Sharma, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Gadolinium in people with Contrast Media Allergy, run by Massachusetts General Hospital 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 1 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: withdrawn, as of the sponsor's last update on 4 May 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?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Vessel enhancement (time frame: Within 1 hour of contrast administration). 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 4 May 2021; AzTrials last refreshed its copy on 7 Nov 2026.