NCT01524016

Brief Summary

Oncogenic osteomalacia is rare disease predominantly caused by a small, somatostatin receptor positive mesenchymal tumor, which is frequently hidden in an unusual anatomical site and often goes undetected by conventional imaging. A permanent cure of the disease relies on exactly localizing the tumor and completely removing it. 68Ga-DOTATATE PET/CT is a novel scan that might have improved sensitivity and resolution specifically for somatostatin receptor positive tumors. The investigators will scan the suspicious and confirmed patients of oncogenic osteomalacia and compare it to 99mTc-HYNIC-TOC SPECT/CT and 18F-FDG PET/CT to see if it improves patient care.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Dec 2011

Longer than P75 for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

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

December 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 29, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 1, 2012

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

April 7, 2017

Status Verified

July 1, 2014

Enrollment Period

6 years

First QC Date

January 29, 2012

Last Update Submit

April 5, 2017

Conditions

Oncogenic OsteomalaciaMesenchymal Tumor

Keywords

Oncogenic osteomalaciamesenchymal tumorSomatostatin receptor68Ga-DOTATATEPET/CT

Outcome Measures

Primary Outcomes (1)

  • Number and location of lesions detected by 68GA-DOTATATE PET/CT compared to 99mTc-HYNIC-TOC SPECT/CT and/or 18F-FDG PET/CT

    Determine if the 68Ga-DOTATATE PET/CT changes care plans compared to conventional imaging/diagnostic techniques (99mTc-HYNIC-TOC SPECT/CT, and/or 18F-FDG PET/CT, MRI, CT, ultrasonography).

    1 year

Secondary Outcomes (1)

  • Number of participants and kinds of adverse events as a measure of safety

    One year

Study Arms (1)

68Ga-DOTATATE, PET/CT scan

EXPERIMENTAL

We will perform 68Ga-DOTATATE PET/CT scanning on subjects

Drug: 68Ga-DOTATATE

Interventions

68Ga-DOTATATEDRUG

Intravenous injection of one dosage of 72-185MBq (2-5 mCi) 68Ga-DOTATATE solution. Tracer doses of 68Ga-DOTATATE will be used to image tumors by Positron Emission Tomography / computed tomography (PET/CT)

Also known as: (68)Ga-DOTA-d-Phe(1),Tyr(3)-octreotate
68Ga-DOTATATE, PET/CT scan

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • In suspicion of oncogenic osteomalacia according to the clinical features such as hyperphosphaturia, hypophosphatemia, low serum vitamin D3 levels, and osteomalacia. Or prior oncogenic osteomalacia patients in suspicion of relapse or with residual tumor
  • At least 18 years old
  • Able to provide informed consent

You may not qualify if:

  • Females planning to bear a child recently or with childbearing potential
  • Renal function: serum creatinine \>3.0 mg/dL (270 μM/L)
  • Liver function: any hepatic enzyme level more than 5 times upper limit of normal.
  • Known severe allergy or hypersensitivity to IV radiographic contrast.
  • Patients not able to enter the bore of the PET/CT scanner.
  • Inability to lie still for the entire imaging time because of cough, pain, etc.
  • Inability to complete the needed examinations due to severe claustrophobia, radiation phobia, etc.
  • Any other medical condition that, in the opinion of the Investigator, may significantly interfere with study compliance.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Nuclear Medicine, Peking Union Medical College Hopital

Beijing, 100730, China

RECRUITING

MeSH Terms

Conditions

Oncogenic osteomalacia

Interventions

gallium Ga 68 dotatate

Study Officials

  • Fang Li, MD

    Department of Nuclear Medicine, Peking Union Medical College Hospital

    STUDY CHAIR

Central Study Contacts

Fang Li, MD

CONTACT

86-10-65295502lifang@pumch.cn

Zhaohui Zhu, MD, PhD

CONTACT

86-10-13611093752zzh_1969@yahoo.com.cn

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2012

First Posted

February 1, 2012

Study Start

December 1, 2011

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

April 7, 2017

Record last verified: 2014-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)