Pulmonary EmbolismPhase 4NCT02234375
Use of Gadolinium in CT Pulmonary Angiography
A Phase 4 study testing Gadolinium in people with Pulmonary Embolism, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The study will investigate patients with clinical suspicion for pulmonary embolism (PE) who have a contraindication to iodine based contrast. These patients normally get investigated with studies such as ultrasound and nuclear medicine studies but the fastest and preferred investigation is CT with contrast to look for… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Pulmonary Embolism
- 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
- Jul 2017to Dec 2019
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients suspected of having a Pulmonary embolus
- Allergy to Iodine based intravenous contrast
Who cannot join
- Renal impairment
- Less than 20 years of age
- Non-English speaking
- Pregnancy
- 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: Efficacy of Gadolinium Contrast in CT Pulmonary Angiography in Patients With Allergy to Iodine
The study will investigate patients with clinical suspicion for pulmonary embolism (PE) who have a contraindication to iodine based contrast. These patients normally get investigated with studies such as ultrasound and nuclear medicine studies but the fastest and preferred investigation is CT with contrast to look for filling defects in the pulmonary arteries. The investigators will assess whether gadolinium, which is currently used with MRI can be used with CT as an alternative effective contrast in diagnosis or exclusion of PE. A new type of CT scanner, a Dual Energy Scanner will be used to improve the visibility of Gadolinium contrast on CT.
Read the detailed description
Contrast enhancement with Gadolinium will be evaluated to assess its efficacy for diagnosis and exclusion of pulmonary embolism in a patient who previously would not have been investigated with CTPA due to an underlying allergy to contrast or other contraindication. If this proves beneficial, it will allow such patients to be investigated successfully with CTPA
- Conditions
- Pulmonary Embolism
- Being tested
- Gadolinium
- Keywords
- Pulmonary embolism, Contrast, Computed tomography, Gadolinium
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GadoliniumDrug
Also called Dotarem
agents will be administered intravenously and a CT scan will be performed to evaluate contrast enhancement characteristics of the agents to assess their 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.
Diagnosis of Pulmonary Embolism
Ability of Gadolinium to diagnose pulmonary embolism on a dual energy CT scan
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2014 (estimated)
- Study startJul 2017 (estimated)
- Primary completionDec 2018 (estimated)
- Study completionDec 2019 (estimated)
Why it stopped: Gadolinium attenuation in vitro inadequate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary EmbolismStudies 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02234375
- Sponsor's protocol ID
- 2012P002535b
- Status last verified
- Feb 2020
- First submitted
- 5 Sep 2014
- Last updated
- 17 Feb 2020
- 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 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Gadolinium Contrast in CT Pulmonary Angiography in Patients With Allergy to Iodine
- ClinicalTrials.gov ID
- NCT02234375
- Acronym / sponsor ID
- 2012P002535b
- Conditions
- Pulmonary Embolism
- Keywords
- Pulmonary embolism, Contrast, Computed tomography, Gadolinium
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Gadolinium attenuation in vitro inadequate
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Jul 2017 (estimated)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 9 Sep 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.
The study will investigate patients with clinical suspicion for pulmonary embolism (PE) who have a contraindication to iodine based contrast. These patients normally get investigated with studies such as ultrasound and nuclear medicine studies but the fastest and preferred investigation is CT with contrast to look for filling defects in the pulmonary arteries. The investigators will assess whether gadolinium, which is currently used with MRI can be used with CT as an alternative effective contrast in diagnosis or exclusion of PE. A new type of CT scanner, a Dual Energy Scanner will be used to improve the visibility of Gadolinium contrast on CT.
Detailed description
Contrast enhancement with Gadolinium will be evaluated to assess its efficacy for diagnosis and exclusion of pulmonary embolism in a patient who previously would not have been investigated with CTPA due to an underlying allergy to contrast or other contraindication. If this proves beneficial, it will allow such patients to be investigated successfully with CTPA
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
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients suspected of having a Pulmonary embolus
- Allergy to Iodine based intravenous contrast
Key exclusion criteria (5 listed)
- Renal impairment
- Less than 20 years of age
- Non-English speaking
- Pregnancy
- 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: Dotaremagents will be administered intravenously and a CT scan will be performed to evaluate contrast enhancement characteristics of the agents to assess their feasibility as an alternative to Iodine based contrast agents | Drug | Gadolinium enhancement |
Primary outcome
Diagnosis of Pulmonary Embolism
Time frame: 24 hours
Ability of Gadolinium to diagnose pulmonary embolism on a dual energy CT scan
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 17 Feb 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Pulmonary Embolism, 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 2 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 17 Feb 2020. 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?
Diagnosis of Pulmonary Embolism (time frame: 24 hours). 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 17 Feb 2020.