PheochromocytomaNCT06669481
Correlation Between Preoperative Images of PPGL and Intraoperative Hemodynamics
An observational study of Pheochromocytoma and Paraganglioma, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
This is a retrospective observational cohort study involving patients with suspected PPGLs who underwent 131I-MIBG scanning and surgical treatment between January 2020 and April 2023. The objective is to evaluate the correlation between MIBG imaging score and intraoperative hemodynamic fluctuations. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pheochromocytoma, Paraganglioma
- What is being tested?
- Semiquantitative 131I-MIBG Scintigraphy Assessment
- Type of treatment
- Injection or infusion
- How many people
- 159 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 30 Apr 2023
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with suspected PPGLs who received 131I-MIBG scintigraphy and were treated by surgery
Who may be able to join
- Patients with suspected PPGLs who received 131I-MIBG scintigraphy and were treated by surgery
Who cannot join
- 1) surgery was performed more than 6 months after 131I-MIBG scintigraphy; 2) tumor located in bladder where radioactive urine would influence assessment of tumor; 3) tumor was not resected as a whole; 4) resected tumor was not PPGLs confirmed by pathology; 5) 131I-MIBG scintigraphy images or intraoperative BP was not available for assessment.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking union medical college hospital
Beijing, Beijing Municipality, 100730
About this study
Official title: Semiquantitative 131I-MIBG Scintigraphy Predicts Intraoperative Blood Pressure Fluctuation in Patients Undergoing Surgery for Pheochromocytoma and Paraganglioma
This is a retrospective observational cohort study involving patients with suspected PPGLs who underwent 131I-MIBG scanning and surgical treatment between January 2020 and April 2023. The objective is to evaluate the correlation between MIBG imaging score and intraoperative hemodynamic fluctuations.
Read the detailed description
This is a retrospective observational cohort study involving patients with suspected PPGLs who underwent 131I-MIBG scanning and surgical treatment between January 2020 and April 2023. The objective is to evaluate the correlation between MIBG imaging score and intraoperative hemodynamic fluctuations.
- Conditions
- Pheochromocytoma, Paraganglioma
- Being tested
- Semiquantitative 131I-MIBG Scintigraphy Assessment
- Medical subject headings
- Pheochromocytoma, Paraganglioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semiquantitative 131I-MIBG Scintigraphy AssessmentOther
Patients received thyroid blockade using solution of potassium iodide before the examination. After intravenous administration of 111 MBq of 131I-MIBG, whole body planar images were acquired at 24 hours (Day 1) and 48 hours (Day 2), respectively.
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference of SBP ARV and MAP ARV in Different Groups
Mean arterial pressure (MAP) was calculated with the formula: MAP=1/3*SBP+2/3*DBP. ARV, which was defined as the average of absolute difference between successive BP values
Measured: Intraoperative systolic blood pressure (SBP) and diastolic blood pressure (DBP) were recorded automatically in a 5 min interval from the beginning to the end of surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2024
- Study start1 Jan 2020
- Primary completion30 Apr 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PheochromocytomaStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06669481
- Sponsor's protocol ID
- K5426
- Other IDs
- National High Level Hospital C
- Status last verified
- Apr 2023
- First submitted
- 30 Oct 2024
- Last updated
- 1 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Semiquantitative 131I-MIBG Scintigraphy Predicts Intraoperative Blood Pressure Fluctuation in Patients Undergoing Surgery for Pheochromocytoma and Paraganglioma
- ClinicalTrials.gov ID
- NCT06669481
- Acronym / sponsor ID
- K5426
- Conditions
- Pheochromocytoma, Paraganglioma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 1 Nov 2024 (actual)
- 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.
This is a retrospective observational cohort study involving patients with suspected PPGLs who underwent 131I-MIBG scanning and surgical treatment between January 2020 and April 2023. The objective is to evaluate the correlation between MIBG imaging score and intraoperative hemodynamic fluctuations.
Detailed description
This is a retrospective observational cohort study involving patients with suspected PPGLs who underwent 131I-MIBG scanning and surgical treatment between January 2020 and April 2023. The objective is to evaluate the correlation between MIBG imaging score and intraoperative hemodynamic fluctuations.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with suspected PPGLs who received 131I-MIBG scintigraphy and were treated by surgery
Key inclusion criteria (1 listed)
- Patients with suspected PPGLs who received 131I-MIBG scintigraphy and were treated by surgery
Key exclusion criteria (1 listed)
- 1) surgery was performed more than 6 months after 131I-MIBG scintigraphy; 2) tumor located in bladder where radioactive urine would influence assessment of tumor; 3) tumor was not resected as a whole; 4) resected tumor was not PPGLs confirmed by pathology; 5) 131I-MIBG scintigraphy images or intraoperative BP was not available for assessment.
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 |
|---|---|---|
| Semiquantitative 131I-MIBG Scintigraphy AssessmentPatients received thyroid blockade using solution of potassium iodide before the examination. After intravenous administration of 111 MBq of 131I-MIBG, whole body planar images were acquired at 24 hours (Day 1) and 48 hours (Day 2), respectively. | Other | – |
Primary outcome
Difference of SBP ARV and MAP ARV in Different Groups
Time frame: Intraoperative systolic blood pressure (SBP) and diastolic blood pressure (DBP) were recorded automatically in a 5 min interval from the beginning to the end of surgery.
Mean arterial pressure (MAP) was calculated with the formula: MAP=1/3*SBP+2/3*DBP. ARV, which was defined as the average of absolute difference between successive BP values
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 1 Nov 2024.
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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?
An observational study of Pheochromocytoma and Paraganglioma, run by Peking Union Medical College Hospital at 1 site in China.
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: finished, as of the sponsor's last update on 1 Nov 2024. 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 China. 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?
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?
Difference of SBP ARV and MAP ARV in Different Groups (time frame: Intraoperative systolic blood pressure (SBP) and diastolic blood pressure (DBP) were recorded automatically in a 5 min interval from the beginning to the end of surgery.). 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 1 Nov 2024.