Pituitary MacroadenomaPhase 2NCT01444209
Radioactive Iodine Implants for Pan-invasive Pituitary Macroadenomas
A Phase 2 study testing Iodine Implants in people with Pituitary Macroadenoma, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
This study is a single arm Phase II pilot trial. Patients enrolled on the trial will undergo implantation of high activity iodine-125 seeds into their pituitary adenoma. The tumor response to treatment will be monitored as well as change in visual fields, associated adverse effects, progression free survival and… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Pituitary Macroadenoma
- What is being tested?
- Iodine Implants
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2011to 20 Jan 2021
- Phase
- Phase 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathological or radiographic diagnosis of a pan-invasive pituitary macroadenoma
- Pan-invasive for the purposes of the protocol will be defined as meeting each of the following 2 major criteria: (1). tumor volume greater than 20 cc at enrollment, and (2). suprasellar extension. In addition, a pan-invasive tumor must meet any one of the following 3 minor criteria, a) unresectable tumor invasion into a cavernous sinus, b) bone or bone marrow invasion into the clivus or temporal bones, or c) tumor extension in any direction unlikely to be completely removed by specifically a transphenoidal surgical approach.
- Patients who meet the two major criteria above (1 and 2) and are medically inoperable for tumor resection (due to confounding co-existing medical problems) are eligible without meeting any of the three minor criteria (a, b, or c).
- Patients should be immediately threatened for vision loss or other significant neurological impairment directly related to tumor mass effect. As such, all patients enrolled would likely benefit from tumor response (shrinkage).
- Patients must have visible tumor on imaging studies (MRI or CT)
- The patient's Zubrod performance status must be 0-3.
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- Patients must be at least 18 years of age.
- Mandatory Imaging Studies: Must be done 45 or fewer days prior to :
- MRI or CT scan of the brain including the entire skull base and all areas of tumor extension
Who cannot join
- Patients who are unable to undergo general anesthesia
- Patients who are unable to undergo placement of a stereotactic head frame
- Patients who are unable to provide informed consent
- Patients who are pregnant or nursing
- Patients with severe kidney dysfunction
- Patients who have contraindications to MRI, such as implanted pacemaker device
- Patients with diagnosis of pituitary carcinoma
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
About this study
Official title: Interstitial Radioactive Iodine Implants for the Treatment of Pan-invasive Pituitary Macroadenomas
This study is a single arm Phase II pilot trial. Patients enrolled on the trial will undergo implantation of high activity iodine-125 seeds into their pituitary adenoma. The tumor response to treatment will be monitored as well as change in visual fields, associated adverse effects, progression free survival and patient reported outcomes.
- Conditions
- Pituitary Macroadenoma
- Being tested
- Iodine Implants
- Keywords
- pituitary gland
- Medical subject headings
- Pituitary Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iodine ImplantsRadiation
Interstitial Radioactive Iodine Implants
| Study group | Role | What they receive |
|---|---|---|
| Radiation Therapy | Experimental | Interstitial Radioactive Iodine Implants Receives: Radiation: Iodine Implants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Partial Response (Reduction in 30% of Tumor Volume) or Greater Response Within 12 Months From the Implant Procedure.
Measured: 12 months
Secondary outcomes (5)
Change of the Patient's Humphrey Visual Field Testing
Measured: 5 years
Potential Toxicities Associated With Interstitial Seed Placement
Measured: 5 years
Progression Free Survival
Measured: 5 years
The Effect of the Treatment on Quality of Life Evaluations (Patient Reported Outcomes)
Measured: 5 years
The Cost-utility of the Treatment Arm (in Terms of the Primary Outcome) in Comparison With Other Widely Accepted Cancer and Non-cancer Therapies
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2011 (estimated)
- Study start30 Sep 2011
- Primary completion20 Oct 2020
- Study completion20 Jan 2021
Why it stopped: Failure to accrue
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 Pituitary MacroadenomaStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Timmerman, University of Texas Southwestern Medical Center
- Investigators
- Robert Timmerman, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01444209
- Sponsor's protocol ID
- STU 042011-075
- Status last verified
- Nov 2021
- First submitted
- 22 Sep 2011
- Last updated
- 30 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interstitial Radioactive Iodine Implants for the Treatment of Pan-invasive Pituitary Macroadenomas
- ClinicalTrials.gov ID
- NCT01444209
- Acronym / sponsor ID
- STU 042011-075
- Conditions
- Pituitary Macroadenoma
- Keywords
- pituitary gland
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Failure to accrue
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 30 Sep 2011 (actual)
- Primary completion
- 20 Oct 2020 (actual)
- Study completion
- 20 Jan 2021 (actual)
- First posted
- 30 Sep 2011 (estimated)
- Results
- Posted 30 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a single arm Phase II pilot trial. Patients enrolled on the trial will undergo implantation of high activity iodine-125 seeds into their pituitary adenoma. The tumor response to treatment will be monitored as well as change in visual fields, associated adverse effects, progression free survival and patient reported outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiation Therapy | Experimental | Radiation: Iodine ImplantsInterstitial Radioactive Iodine Implants |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Pathological or radiographic diagnosis of a pan-invasive pituitary macroadenoma
- Pan-invasive for the purposes of the protocol will be defined as meeting each of the following 2 major criteria: (1). tumor volume greater than 20 cc at enrollment, and (2). suprasellar extension. In addition, a pan-invasive tumor must meet any one of the following 3 minor criteria, a) unresectable tumor invasion into a cavernous sinus, b) bone or bone marrow invasion into the clivus or temporal bones, or c) tumor extension in any direction unlikely to be completely removed by specifically a transphenoidal surgical approach.
- Patients who meet the two major criteria above (1 and 2) and are medically inoperable for tumor resection (due to confounding co-existing medical problems) are eligible without meeting any of the three minor criteria (a, b, or c).
- Patients should be immediately threatened for vision loss or other significant neurological impairment directly related to tumor mass effect. As such, all patients enrolled would likely benefit from tumor response (shrinkage).
- Patients must have visible tumor on imaging studies (MRI or CT)
Key exclusion criteria (7 listed)
- Patients who are unable to undergo general anesthesia
- Patients who are unable to undergo placement of a stereotactic head frame
- Patients who are unable to provide informed consent
- Patients who are pregnant or nursing
- Patients with severe kidney dysfunction
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 |
|---|---|---|
| Iodine ImplantsInterstitial Radioactive Iodine Implants | Radiation | Radiation Therapy |
Primary outcome
Partial Response (Reduction in 30% of Tumor Volume) or Greater Response Within 12 Months From the Implant Procedure.
Time frame: 12 months
5 secondary outcomes
Change of the Patient's Humphrey Visual Field Testing
Time frame: 5 years
Potential Toxicities Associated With Interstitial Seed Placement
Time frame: 5 years
Progression Free Survival
Time frame: 5 years
The Effect of the Treatment on Quality of Life Evaluations (Patient Reported Outcomes)
Time frame: 5 years
The Cost-utility of the Treatment Arm (in Terms of the Primary Outcome) in Comparison With Other Widely Accepted Cancer and Non-cancer Therapies
Time frame: 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Pituitary Macroadenoma
Enrolling by invitationPhase 4
Randomized Controlled Clinical Study on the Prophylactic Intraoperative Use of Desmopressin in Complex Sellar Region Tumors
Craniopharyngiomas, Pituitary Macroadenoma
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.
Robert Timmerman, MD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Iodine Implants in people with Pituitary Macroadenoma, run by University of Texas Southwestern Medical Center 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 9 inclusion and 7 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: stopped early, as of the sponsor's last update on 30 Nov 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 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 30 Nov 2021). 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?
Partial Response (Reduction in 30% of Tumor Volume) or Greater Response Within 12 Months From the Implant Procedure. (time frame: 12 months). 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 30 Nov 2021.