Ga-DOTATATE PET Imaging for Osteomalacia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new imaging technique called Ga-DOTATATE PET/CT to determine if it can better detect the source of a hormone that causes low phosphate levels, leading to osteomalacia (softening of the bones). The goal is to enhance how doctors identify and treat this condition. Adults previously treated for a specific form of osteomalacia at the Mayo Clinic are ideal candidates for this study. As a Phase 1 and Phase 2 trial, it aims to understand how the technique works and measure its effectiveness in an initial group, offering participants a chance to contribute to groundbreaking research.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
What prior data suggests that this imaging technique is safe?
Research has shown that 68Ga-DOTATATE PET/CT scans have been extensively studied for safety. Most patients find it generally easy to handle, and studies have not reported any major safety issues. In fact, it has been used successfully to diagnose certain tumors without causing significant side effects.
Although this specific trial is in its early stages, the use of 68Ga-DOTATATE PET/CT in other cases suggests it is safe for patients. Discussing any concerns with a doctor is advisable, but the research so far appears promising for safety.12345Why are researchers excited about this trial?
Unlike traditional treatments for osteomalacia, which often involve vitamin D and phosphate supplements, 68Ga-DOTATATE PET/CT imaging offers a novel approach by utilizing a radioactive tracer, 68Ga-DOTATATE, to visualize areas of the body with abnormal bone metabolism. This technique is unique because it targets somatostatin receptors, providing high-resolution images that can help pinpoint the exact location and extent of bone lesions. Researchers are excited about this method because it could lead to more accurate diagnoses and, in turn, more effective treatment plans for patients with osteomalacia.
What evidence suggests that this imaging technique is effective for osteomalacia?
Research has shown that 68Ga-DOTATATE PET/CT, the imaging method used in this trial, effectively identifies the cause of low phosphate levels in the body. One study found a high accuracy rate of 95.13% in pinpointing the problem. This indicates its ability to correctly detect issues related to low phosphate levels in many cases. Another study demonstrated that this imaging method significantly aided the treatment of 80% of patients. Compared to other imaging techniques, 68Ga-DOTATATE PET/CT has proven superior in locating tumors responsible for these phosphate issues. Overall, these findings suggest that this imaging method is a promising tool for diagnosing and managing conditions related to low phosphate levels.678910
Who Is on the Research Team?
Matthew Drake, MD
Principal Investigator
Mayo Clinic
Stephen M Broski, MD
Principal Investigator
Mayo Clinic
Are You a Good Fit for This Trial?
This trial is for adults over 18 who have been seen at Mayo Clinic, Rochester for FGF23 mediated osteomalacia between 2000 and 2018. Participants must consent to the study. It excludes prisoners, pregnant individuals, those with heritable forms of the condition or those who've already had successful tumor localization and resection.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Imaging
Participants undergo 68Ga-DOTATATE PET/CT imaging to localize phosphaturic mesenchymal tumors
Follow-up
Participants are monitored for safety and effectiveness after imaging, with results discussed by the endocrinologist
What Are the Treatments Tested in This Trial?
Interventions
- 68Ga-DOTATATE PET/CT
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mayo Clinic
Lead Sponsor