NCT06669481

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
159

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

October 30, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 1, 2024

Completed
Last Updated

November 1, 2024

Status Verified

April 1, 2023

Enrollment Period

3.3 years

First QC Date

October 30, 2024

Last Update Submit

October 30, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    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.

Interventions

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.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with suspected PPGLs who received 131I-MIBG scintigraphy and were treated by surgery

You may qualify if:

  • Patients with suspected PPGLs who received 131I-MIBG scintigraphy and were treated by surgery

You may not qualify if:

  • \) 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking union medical college hospital

Beijing, Beijing Municipality, 100730, China

Location

MeSH Terms

Conditions

PheochromocytomaParaganglioma

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve Tissue

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2024

First Posted

November 1, 2024

Study Start

January 1, 2020

Primary Completion

April 30, 2023

Study Completion

April 30, 2023

Last Updated

November 1, 2024

Record last verified: 2023-04

Locations