Osteomalacia
Conditions
Keywords
FGF 23, oncogenic, tumor induced
Brief summary
The researchers are trying to evaluate a newer imaging technique (Ga-DOTATATE PET/CT) to see if it is more sensitive to localize the source of the hormone, which has caused the low phosphate levels.
Detailed description
Subjects will be contacted (phone script attached) to inform them of the study and the imaging modality. The first 10 patients that agree to participate in the study will be asked to present to the Mayo Clinic where they can provide a written consent and perform the imaging study. Enrolled subjects will be evaluated in the clinical practice prior to having 68Ga-DOTATATE PET/CT imaging performed. The treating endocrinologist will be informed of the imaging results and will review the results with the subject using a follow-up visit or phone call; when a tumor is localized, the endocrinologist will discuss appropriate management options. Subjects will be follow for one year post 68Ga-DOTATATE PET/CT.
Interventions
COMBINATION_PRODUCT68Ga-DOTATATE PET/CT
Gallium-68 Dotatate, a radioactive imaging agent, is injected into a vein. Subjects will rest for approximately 50 minutes, after which approximately a 30 minute image of subjects body will be completed via PET/CT scan.
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults (18 years of age or older) seen at Mayo Clinic, Rochester for FGF23 mediated osteomalacia between 1/1/2000 and 1/30/2018 who provide informed consent to participate in the study.
Exclusion criteria
* Pregnant * Prisoners * Subjects diagnosed with heritable hypophosphatemic rickets/osteomalacia * Subjects who do not consent for the study or withdraw consent during the duration of the study. * Subjects in whom tumor localization and successful resection has already occurred.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Positive Localization of Phosphaturic Mesenchymal Tumors (PMTs) | One year | 68Ga-DOTATATE PET maximum intensity projection images will be analyzed to evaluate for the localization of phosphaturic mesenchymal tumors (PMTs). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 68Ga-DOTATATE PET/CT Subjects will undergo imaging by 68Ga-DOTATATE PET/CT
68Ga-DOTATATE PET/CT: Gallium-68 Dotatate, a radioactive imaging agent, is injected into a vein. Subjects will rest for approximately 50 minutes, after which approximately a 30 minute image of subjects body will be completed via PET/CT scan. | 18 |
| Total | 18 |
Baseline characteristics
| Characteristic | 68Ga-DOTATATE PET/CT |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 5 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants |
| Age, Continuous | 52.6 years STANDARD_DEVIATION 13.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 16 Participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 18 |
| other Total, other adverse events | 0 / 18 |
| serious Total, serious adverse events | 0 / 18 |
Outcome results
Primary
Number of Participants With Positive Localization of Phosphaturic Mesenchymal Tumors (PMTs)
68Ga-DOTATATE PET maximum intensity projection images will be analyzed to evaluate for the localization of phosphaturic mesenchymal tumors (PMTs).
Time frame: One year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 68Ga-DOTATATE PET/CT | Number of Participants With Positive Localization of Phosphaturic Mesenchymal Tumors (PMTs) | 15 Participants |