Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00099762
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2004-12-17
Brief Title:
Catheterization to Locate Mesenchymal Tumors in Patients With Tumor-Induced Osteomalacia or Oncogenic Osteomalacia
Sponsor:
National Institute of Dental and Craniofacial Research NIDCR
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Selective Venous Catheterization for the Localization of Phosphaturic Mesenchymal Tumors
Status:
COMPLETED
Status Verified Date:
2009-09-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will use a procedure called selective venous catheterization in patients with tumor-induced osteomalacia TIO or oncogenic osteomalacia OOM to try to locate very small tumors that produce proteins called phosphatonins Too much phosphatonin in the blood causes the kidneys to allow large amounts of phosphorus to be excreted in the urine leading to low blood levels of phosphorus and in turn to osteomalacia a condition of soft bones Osteomalacia can cause bone fractures requiring many surgical procedures that can leave patients in pain Patients may also feel weak and can lose height from massive bone loss Selective venous catheterization is a way to measure the amount of phosphatonin in the blood and may be used as a way to locate phosphatonin-producing tumors that cannot be found using standard imaging techniques
Patients with TIO or OOM are screened under NIDR Protocol 01-D-0184 with a medical history review of medical records and routine physical examination Other procedures may include blood tests urine tests and imaging tests such as x-rays bone densitometry bone scan computed tomography CT and magnetic resonance imaging MRI This study will include mostly patients whose tumors were not able to be located through imaging procedures but also a few patients whose tumors were located
All participants regardless of whether or not their tumor was located undergo selective venous catheterization For this procedure a radiologist inserts a catheter thin flexible tube into the body and uses fluoroscopy a type of x-ray to guide the tip of the catheter to different places in the body to collect small amounts of blood from the different areas After the procedure the patient lies flat for 2 hours and avoids moving his or her leg on the side where the catheter was placed
The blood is analyzed to measure the amount phosphatonin is in each sample and the amounts are compared to the average amount of phosphatonin in the general blood circulation If a higher level of phosphatonin is found in one area and the location of the tumor is unknown the patient undergoes imaging in that area If a tumor is found and it is in an area where it can be removed surgically the patient is given the option to have the surgery If the tumor is not found by imaging done after the first catheterization procedure the patient has the option to have a second catheterization taking samples of blood only from the area where the phosphatonin was found to be the highest during the sampling procedure
Patients with TIO or OOM are screened under NIDR Protocol 01-D-0184 with a medical history review of medical records and routine physical examination Other procedures may include blood tests urine tests and imaging tests such as x-rays bone densitometry bone scan computed tomography CT and magnetic resonance imaging MRI This study will include mostly patients whose tumors were not able to be located through imaging procedures but also a few patients whose tumors were located
All participants regardless of whether or not their tumor was located undergo selective venous catheterization For this procedure a radiologist inserts a catheter thin flexible tube into the body and uses fluoroscopy a type of x-ray to guide the tip of the catheter to different places in the body to collect small amounts of blood from the different areas After the procedure the patient lies flat for 2 hours and avoids moving his or her leg on the side where the catheter was placed
The blood is analyzed to measure the amount phosphatonin is in each sample and the amounts are compared to the average amount of phosphatonin in the general blood circulation If a higher level of phosphatonin is found in one area and the location of the tumor is unknown the patient undergoes imaging in that area If a tumor is found and it is in an area where it can be removed surgically the patient is given the option to have the surgery If the tumor is not found by imaging done after the first catheterization procedure the patient has the option to have a second catheterization taking samples of blood only from the area where the phosphatonin was found to be the highest during the sampling procedure
Detailed Description:
Phosphaturic mesenchymal tumors elaborate phosphate lowering factors phosphatonins which lead to tumor induced osteomalaciaosteogenic osteomalacia TIOOOM Patients with TIOOOM suffer years of significant morbidity and debilitation unless their tumors which are notoriously difficult to locate are removed
Selective venous catheterization has been used to localize hormonally active neoplasms by demonstrating a gradient in the concentration of the hormone of interest between the vessel immediately draining the tumor site and the peripheral circulation The primary objective of this protocol is to evaluate the utility of combining selective venous catheterization with biochemical assays that identify phosphatonins in the serum as a way to identify phosphatonin gradients and thereby localize phosphaturic tumors
Our study population will consist of TIOOOM patients with non-localized phosphaturic tumors as well as five patients whose lesions have been identified with some certainty by conventional imaging techniques These individuals will undergo selective venous catheterization during which blood samples will be obtained and processed for the presence of phosphatonins The primary endpoint will be met if a gradient indicating a possible tumor is found focused clinical imaging in the appropriate anatomical sub-region identifies a lesion and the lesion is confirmed to be a phosphaturic mesenchymal tumor upon surgical removal
Selective venous catheterization has been used to localize hormonally active neoplasms by demonstrating a gradient in the concentration of the hormone of interest between the vessel immediately draining the tumor site and the peripheral circulation The primary objective of this protocol is to evaluate the utility of combining selective venous catheterization with biochemical assays that identify phosphatonins in the serum as a way to identify phosphatonin gradients and thereby localize phosphaturic tumors
Our study population will consist of TIOOOM patients with non-localized phosphaturic tumors as well as five patients whose lesions have been identified with some certainty by conventional imaging techniques These individuals will undergo selective venous catheterization during which blood samples will be obtained and processed for the presence of phosphatonins The primary endpoint will be met if a gradient indicating a possible tumor is found focused clinical imaging in the appropriate anatomical sub-region identifies a lesion and the lesion is confirmed to be a phosphaturic mesenchymal tumor upon surgical removal
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 05-D-0050 | None | None | None |