Uveal MelanomaNCT00459849
Tilting of Radioactive Plaques After Initial Accurate Placement for Treatment of Uveal Melanoma
A study testing Intraoperative ultrasonography in people with Uveal Melanoma, run by Barnes Retina Institute at 1 site in United States.
Trial summary
Plaque radiotherapy is a common treatment for uveal melanoma. However, local failure has been reported in up to 20% of patients. We use intraoperative ultrasonography at plaque insertion and removal to evaluate plaque movement as a potential factor in local failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uveal Melanoma
- What is being tested?
- Intraoperative ultrasonography
- Type of treatment
- Surgery or procedure
- How many people
- 175 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2000to Jul 2007
- Phase
- Interventional
- 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
Who may be able to join
- All patients with uveal melanoma treated with brachytherapy
Who cannot join
- Ciliary melanoma
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University in St. Louis School of Medicine
St Louis, Missouri, 63110
About this study
Plaque radiotherapy is a common treatment for uveal melanoma. However, local failure has been reported in up to 20% of patients. We use intraoperative ultrasonography at plaque insertion and removal to evaluate plaque movement as a potential factor in local failure.
Read the detailed description
Episcleral plaque radiotherapy is a common treatment for uveal melanoma and results in local tumor control in most cases. However, local failure has been reported in a substantial proportion of patients. Since local failure greatly increases the risk of metastatic death, identifying and correcting the causes of local treatment failure are of paramount importance. Poor plaque localization is an important contributing factor to local failure. With the aid of intraoperative ultrasonography, most malpositioned plaques can be identified and readjusted at the time of plaque insertion. However, little is known about plaque movement during the 4-5 days of brachytherapy, which could also contribute to local failure. To address this question, we perform intraoperative B-scan ultrasonography at the time of iodine-125 radioactive plaque insertion and removal in uveal melanoma patients.
- Conditions
- Uveal Melanoma
- Being tested
- Intraoperative ultrasonography
- Keywords
- Melanoma, Brachytherapy, Ultrasonography
- Medical subject headings
- Uveal Melanoma, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative ultrasonographyProcedure or surgery
Intraoperative ultrasonography will be used to determine plaque placement.
What is being measured
The primary outcome is the main question the study is designed to answer.
Plaque tilt using intraoperative ultrasonography
Measured: End of study
Local melanoma failure
Measured: End of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2007 (estimated)
- Study startJul 2000
- Primary completionJul 2007 (estimated)
- Study completionJul 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Uveal MelanomaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 175 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Barnes Retina Institute
- Sponsor type
- University, hospital or other
- Investigators
- J W Harbour, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00459849
- Sponsor's protocol ID
- HRPO# 07-0092
- Status last verified
- May 2008
- First submitted
- 11 Apr 2007
- Last updated
- 9 May 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Harbour JW. Clinical overview of uveal melanoma: introduction to tumors of the eye. In: Albert DM, Polans A, eds. Ocular Oncology. New York: Marcel Dekker; 2003:1-18.
Char DH, Quivey JM, Castro JR, Kroll S, Phillips T. Helium ions versus iodine 125 brachytherapy in the management of uveal melanoma. A prospective, randomized, dynamically balanced trial. Ophthalmology. 1993 Oct;100(10):1547-54. doi: 10.1016/s0161-6420(93)31446-6.
PubMed 8414414Garretson BR, Robertson DM, Earle JD. Choroidal melanoma treatment with iodine 125 brachytherapy. Arch Ophthalmol. 1987 Oct;105(10):1394-7. doi: 10.1001/archopht.1987.01060100096035.
PubMed 3310986Karlsson UL, Augsburger JJ, Shields JA, Markoe AM, Brady LW, Woodleigh R. Recurrence of posterior uveal melanoma after 60Co episcleral plaque therapy. Ophthalmology. 1989 Mar;96(3):382-8. doi: 10.1016/s0161-6420(89)32882-x.
PubMed 2710530Quivey JM, Augsburger J, Snelling L, Brady LW. 125I plaque therapy for uveal melanoma. Analysis of the impact of time and dose factors on local control. Cancer. 1996 Jun 1;77(11):2356-62. doi: 10.1002/(SICI)1097-0142(19960601)77:113.0.CO;2-V.
PubMed 8635107Almony A, Breit S, Zhao H, Garcia-Ramirez J, Mansur DB, Harbour JW. Tilting of radioactive plaques after initial accurate placement for treatment of uveal melanoma. Arch Ophthalmol. 2008 Jan;126(1):65-70. doi: 10.1001/archophthalmol.2007.9.
PubMed 18195220
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tilting of Radioactive Plaques After Initial Accurate Placement for Treatment of Uveal Melanoma
- ClinicalTrials.gov ID
- NCT00459849
- Acronym / sponsor ID
- HRPO# 07-0092
- Conditions
- Uveal Melanoma
- Keywords
- Melanoma, Brachytherapy, Ultrasonography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 175 participants (estimated)
- Lead sponsor
- Barnes Retina InstituteUniversity, hospital or other
- Study start
- Jul 2000
- Primary completion
- Jul 2007 (estimated)
- Study completion
- Jul 2007 (estimated)
- First posted
- 13 Apr 2007 (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.
Plaque radiotherapy is a common treatment for uveal melanoma. However, local failure has been reported in up to 20% of patients. We use intraoperative ultrasonography at plaque insertion and removal to evaluate plaque movement as a potential factor in local failure.
Detailed description
Episcleral plaque radiotherapy is a common treatment for uveal melanoma and results in local tumor control in most cases. However, local failure has been reported in a substantial proportion of patients. Since local failure greatly increases the risk of metastatic death, identifying and correcting the causes of local treatment failure are of paramount importance. Poor plaque localization is an important contributing factor to local failure. With the aid of intraoperative ultrasonography, most malpositioned plaques can be identified and readjusted at the time of plaque insertion. However, little is known about plaque movement during the 4-5 days of brachytherapy, which could also contribute to local failure. To address this question, we perform intraoperative B-scan ultrasonography at the time of iodine-125 radioactive plaque insertion and removal in uveal melanoma patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients with uveal melanoma treated with brachytherapy
Key exclusion criteria (1 listed)
- Ciliary melanoma
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 |
|---|---|---|
| Intraoperative ultrasonographyIntraoperative ultrasonography will be used to determine plaque placement. | Procedure or surgery | – |
Primary outcome
Plaque tilt using intraoperative ultrasonography
Time frame: End of study
Local melanoma failure
Time frame: End of study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2008.
- BackgroundHarbour JW. Clinical overview of uveal melanoma: introduction to tumors of the eye. In: Albert DM, Polans A, eds. Ocular Oncology. New York: Marcel Dekker; 2003:1-18.
- Background: PubMed 8414414Char DH, Quivey JM, Castro JR, Kroll S, Phillips T. Helium ions versus iodine 125 brachytherapy in the management of uveal melanoma. A prospective, randomized, dynamically balanced trial. Ophthalmology. 1993 Oct;100(10):1547-54. doi: 10.1016/s0161-6420(93)31446-6.
- Background: PubMed 3310986Garretson BR, Robertson DM, Earle JD. Choroidal melanoma treatment with iodine 125 brachytherapy. Arch Ophthalmol. 1987 Oct;105(10):1394-7. doi: 10.1001/archopht.1987.01060100096035.
- Background: PubMed 2710530Karlsson UL, Augsburger JJ, Shields JA, Markoe AM, Brady LW, Woodleigh R. Recurrence of posterior uveal melanoma after 60Co episcleral plaque therapy. Ophthalmology. 1989 Mar;96(3):382-8. doi: 10.1016/s0161-6420(89)32882-x.
- Background: PubMed 8635107Quivey JM, Augsburger J, Snelling L, Brady LW. 125I plaque therapy for uveal melanoma. Analysis of the impact of time and dose factors on local control. Cancer. 1996 Jun 1;77(11):2356-62. doi: 10.1002/(SICI)1097-0142(19960601)77:113.0.CO;2-V.
- Derived from this study: PubMed 18195220Almony A, Breit S, Zhao H, Garcia-Ramirez J, Mansur DB, Harbour JW. Tilting of radioactive plaques after initial accurate placement for treatment of uveal melanoma. Arch Ophthalmol. 2008 Jan;126(1):65-70. doi: 10.1001/archophthalmol.2007.9.
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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.
J W Harbour, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraoperative ultrasonography in people with Uveal Melanoma, run by Barnes Retina Institute 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 1 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 9 May 2008. 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?
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?
Plaque tilt using intraoperative ultrasonography (time frame: End of study). 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?
On the ClinicalTrials.gov record for NCT00459849, which also lists 6 linked publications.
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 9 May 2008.