Abdominal NeoplasmsPhase 1NCT00186953
Determination of a Safe Dose of Optison in Pediatric Patients With Solid Tumors
A Phase 1 study testing Optison in people with Abdominal Neoplasms and Pelvic Neoplasms, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial summary
St. Jude Children's Research Hospital is studying ways to make ultrasound images clearer - to be able to see blood vessels, body structures, and tumors better. Ultrasound uses sound waves to create pictures, allowing doctors and other medical professionals to "see" inside the body. Read more about this study
- Who is it for?
- Ages 2 to 20 years
- Conditions the study is for
- Abdominal Neoplasms, Pelvic Neoplasms
- What is being tested?
- Optison
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2002to Aug 2004
- 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 2 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age: 2-20 years old
- Subject has a known or suspected solid soft tissue tumor in the abdomen or pelvis.
- Subject is scheduled for other imaging or is already scheduled for an ultrasound or has already had adequate imaging performed at an outside institution.
- Subject is able to lie still for the exam without sedation.
Who cannot join
- Known or suspected hypersensitivity to albumin, blood or blood products.
- History of open heart surgery, cyanotic congenital heart disease or an axygen saturation of less than 96% as determined by pulse oximetry.
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
About this study
Official title: Determination of Optimal Dose and Safety Profile of Optison Ultrasound Contrast Agent in Pediatric Solid Tumor Patients
St. Jude Children's Research Hospital is studying ways to make ultrasound images clearer - to be able to see blood vessels, body structures, and tumors better. Ultrasound uses sound waves to create pictures, allowing doctors and other medical professionals to "see" inside the body.
Researchers are studying a contrast agent (like a dye) called Optison™. St. Jude Children's Research Hospital researchers want to learn the best and safest dose of this ultrasound "dye."
- Conditions
- Abdominal Neoplasms, Pelvic Neoplasms
- Being tested
- Optison
- Keywords
- Ultrasound, Abdominal tumors, Pelvic tumors
- Medical subject headings
- Abdominal Neoplasms, Pelvic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OptisonDrug
Intervention description:
Based on recommendation by the FDA, we began with a dose of 0.125ml/m^2 and escalated at 0.15 ml/m^2 increments, to 0.275 ml/m^2 and 0.425ml/m^2 and 0.500ml/m^2. We will now continue to escalate the dose of Optison at 0.300ml/m^2 increments to a maximum single dose of 4ml or a total cumulative dose of 8.7 ml as recommended by the manufacturer.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Not described Receives: Drug: Optison |
What is being measured
The primary outcome is the main question the study is designed to answer.
To learn the best dose of Optison™ ultrasound contrast agent that can be safely given to children with abdominal or pelvic tumors.
Measured: Unknown-study temporarily closed.
To learn the effects (good and bad) of using Optison during ultrasound.
Measured: Unknown-study temporarily closed.
To learn if using Optison™ during ultrasound can show the size and location of a tumor, how the tumor is responding to chemotherapy, and whether it has moved into surrounding tissue.
Measured: Unknown-study temporarily closed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startJun 2002
- Primary completionAug 2004
- Study completionAug 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Abdominal NeoplasmsStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mary E. McCarville, M.D., Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00186953
- Sponsor's protocol ID
- OPTUS
- Status last verified
- Sep 2011
- First submitted
- 12 Sep 2005
- Last updated
- 20 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Anderson LN, Maguire JL, Lebovic G, Hanley AJ, Hamilton J, Adeli K, McCrindle BW, Borkhoff CM, Parkin PC, Birken CS; Applied Research Group for Kids! (TARGet Kids!) Collaboration. Duration of Fasting, Serum Lipids, and Metabolic Profile in Early Childhood. J Pediatr. 2017 Jan;180:47-52.e1. doi: 10.1016/j.jpeds.2016.09.005. Epub 2016 Oct 11.
PubMed 27742126
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Optimal Dose and Safety Profile of Optison Ultrasound Contrast Agent in Pediatric Solid Tumor Patients
- ClinicalTrials.gov ID
- NCT00186953
- Acronym / sponsor ID
- OPTUS
- Conditions
- Abdominal Neoplasms, Pelvic Neoplasms
- Keywords
- Ultrasound, Abdominal tumors, Pelvic tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Study start
- Jun 2002
- Primary completion
- Aug 2004 (actual)
- Study completion
- Aug 2004 (actual)
- First posted
- 16 Sep 2005 (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.
St. Jude Children's Research Hospital is studying ways to make ultrasound images clearer - to be able to see blood vessels, body structures, and tumors better. Ultrasound uses sound waves to create pictures, allowing doctors and other medical professionals to "see" inside the body.
Researchers are studying a contrast agent (like a dye) called Optison™. St. Jude Children's Research Hospital researchers want to learn the best and safest dose of this ultrasound "dye."
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Drug: Optison |
Who may qualify
- Ages
- 2 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Age: 2-20 years old
- Subject has a known or suspected solid soft tissue tumor in the abdomen or pelvis.
- Subject is scheduled for other imaging or is already scheduled for an ultrasound or has already had adequate imaging performed at an outside institution.
- Subject is able to lie still for the exam without sedation.
Key exclusion criteria (2 listed)
- Known or suspected hypersensitivity to albumin, blood or blood products.
- History of open heart surgery, cyanotic congenital heart disease or an axygen saturation of less than 96% as determined by pulse oximetry.
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 |
|---|---|---|
| OptisonIntervention description: Based on recommendation by the FDA, we began with a dose of 0.125ml/m^2 and escalated at 0.15 ml/m^2 increments, to 0.275 ml/m^2 and 0.425ml/m^2 and 0.500ml/m^2. We will now continue to escalate the dose of Optison at 0.300ml/m^2 increments to a maximum single dose of 4ml or a total cumulative dose of 8.7 ml as recommended by the manufacturer. | Drug | 1 |
Primary outcome
To learn the best dose of Optison™ ultrasound contrast agent that can be safely given to children with abdominal or pelvic tumors.
Time frame: Unknown-study temporarily closed.
To learn the effects (good and bad) of using Optison during ultrasound.
Time frame: Unknown-study temporarily closed.
To learn if using Optison™ during ultrasound can show the size and location of a tumor, how the tumor is responding to chemotherapy, and whether it has moved into surrounding tissue.
Time frame: Unknown-study temporarily closed.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2011.
- Derived from this study: PubMed 27742126Anderson LN, Maguire JL, Lebovic G, Hanley AJ, Hamilton J, Adeli K, McCrindle BW, Borkhoff CM, Parkin PC, Birken CS; Applied Research Group for Kids! (TARGet Kids!) Collaboration. Duration of Fasting, Serum Lipids, and Metabolic Profile in Early Childhood. J Pediatr. 2017 Jan;180:47-52.e1. doi: 10.1016/j.jpeds.2016.09.005. Epub 2016 Oct 11.
- St. Jude Children's Research HospitalLink provided by the sponsor.
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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.
Mary E. McCarville, M.D. principal investigator
St. Jude Children's Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Optison in people with Abdominal Neoplasms and Pelvic Neoplasms, run by St. Jude Children's Research 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 4 inclusion and 2 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 20 Sep 2011. 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 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To learn the best dose of Optison™ ultrasound contrast agent that can be safely given to children with abdominal or pelvic tumors. (time frame: Unknown-study temporarily closed.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00186953, which also lists 1 linked publication.
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 20 Sep 2011.