Oncogenic OsteomalaciaEarly Phase 1NCT01524016
68Ga-DOTATATE PET/CT in Oncogenic Osteomalacia
A Early Phase 1 study testing 68Ga-DOTATATE in people with Oncogenic Osteomalacia and Mesenchymal Tumor, run by Peking Union Medical College Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Oncogenic Osteomalacia, Mesenchymal Tumor
- What is being tested?
- 68Ga-DOTATATE
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Dec 2011to Dec 2017
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Nuclear Medicine, Peking Union Medical College Hopital
Beijing, 100730
Fang Li, MD, 86-10-65295502, lifang@pumch.cn
Zhaohui Zhu, MD, PhD, 86-10-13611093752, zzh_1969@yahoo.com.cn
About this study
Official title: 68Ga-DOTATATE PET/CT for Detection and Evaluation of the Causative Tumor of Oncogenic Osteomalacia
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.
Read the detailed description
Oncogenic osteomalacia, or tumor-induced osteomalacia, is a rare, serious paraneoplastic syndrome. It is predominantly driven by a small, benign mesenchymal tumor. The disease is readily prompted by the clinical features such as hyperphosphaturia, hypophosphatemia, low serum vitamin D3 levels, elevated serum fibroblast growth factor 23 levels, and osteomalacia. However, the causative tumor is frequently hidden in an unusual anatomical site and often goes undetected by conventional imaging, such as computed tomography (CT), while a permanent cure of the disease will only rely on exact localization and completely removal of the tumor.
Since mesenchymal tumors express somatostatin receptors (SSR), molecular imaging using radiolabeled somatostatin analogs may be one of the best ways to detect the small, occult tumors. 111In- and 99mTc-labeled octreotide and analogs have been proved useful to detect mesenchymal tumor and other SSR-positive tumors. However, the scintigraphy is insufficient to provide high-resolution images and precise anatomical information. In this study, a novel approach was proposed for exact localization of mesenchymal tumors through positron emission tomography (PET) imaging with 68Ga-DOTATATE and co-registration with CT. 68Ga-DOTATATE PET/CT is a novel method that might have improved sensitivity and resolution specifically for SSR-positive tumors, including the causative tumor of oncogenic osteomalacia.
The investigators will scan the patients in suspicion of oncogenic osteomalacia and the confirmed oncogenic osteomalacia patients in suspicion of relapse or with residual tumor after surgery, and compare it to 99mTc-HYNIC-TOC SPECT/CT and 18F-FDG PET/CT of the same patients. The aim of the study was to see if 68Ga-DOTATATE PET/CT can detect more tumors with higher resolution and more exact localization, and then help to develop optimal treatment strategy and improves patient care.
- Conditions
- Oncogenic Osteomalacia, Mesenchymal Tumor
- Being tested
- 68Ga-DOTATATE
- Keywords
- Oncogenic osteomalacia, mesenchymal tumor, Somatostatin receptor, 68Ga-DOTATATE, PET/CT
- Medical subject headings
- Oncogenic osteomalacia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-DOTATATEDrug
Also called (68)Ga-DOTA-d-Phe(1),Tyr(3)-octreotate
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)
| Study group | Role | What they receive |
|---|---|---|
| 68Ga-DOTATATE, PET/CT scan | Experimental | We will perform 68Ga-DOTATATE PET/CT scanning on subjects Receives: Drug: 68Ga-DOTATATE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 year
Secondary outcomes (1)
Number of participants and kinds of adverse events as a measure of safety
Determine if any adverse effects are associated with the scan and the number of patients that experience them.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2012 (estimated)
- Study startDec 2011
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oncogenic OsteomalaciaStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fang Li, MD, Study chair, Department of Nuclear Medicine, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01524016
- Sponsor's protocol ID
- PUMCHNM001
- Status last verified
- Jul 2014
- First submitted
- 29 Jan 2012
- Last updated
- 7 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 68Ga-DOTATATE PET/CT for Detection and Evaluation of the Causative Tumor of Oncogenic Osteomalacia
- ClinicalTrials.gov ID
- NCT01524016
- Acronym / sponsor ID
- PUMCHNM001
- Conditions
- Oncogenic Osteomalacia, Mesenchymal Tumor
- Keywords
- Oncogenic osteomalacia, mesenchymal tumor, Somatostatin receptor, 68Ga-DOTATATE, PET/CT
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 1 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Oncogenic osteomalacia, or tumor-induced osteomalacia, is a rare, serious paraneoplastic syndrome. It is predominantly driven by a small, benign mesenchymal tumor. The disease is readily prompted by the clinical features such as hyperphosphaturia, hypophosphatemia, low serum vitamin D3 levels, elevated serum fibroblast growth factor 23 levels, and osteomalacia. However, the causative tumor is frequently hidden in an unusual anatomical site and often goes undetected by conventional imaging, such as computed tomography (CT), while a permanent cure of the disease will only rely on exact localization and completely removal of the tumor.
Since mesenchymal tumors express somatostatin receptors (SSR), molecular imaging using radiolabeled somatostatin analogs may be one of the best ways to detect the small, occult tumors. 111In- and 99mTc-labeled octreotide and analogs have been proved useful to detect mesenchymal tumor and other SSR-positive tumors. However, the scintigraphy is insufficient to provide high-resolution images and precise anatomical information. In this study, a novel approach was proposed for exact localization of mesenchymal tumors through positron emission tomography (PET) imaging with 68Ga-DOTATATE and co-registration with CT. 68Ga-DOTATATE PET/CT is a novel method that might have improved sensitivity and resolution specifically for SSR-positive tumors, including the causative tumor of oncogenic osteomalacia.
The investigators will scan the patients in suspicion of oncogenic osteomalacia and the confirmed oncogenic osteomalacia patients in suspicion of relapse or with residual tumor after surgery, and compare it to 99mTc-HYNIC-TOC SPECT/CT and 18F-FDG PET/CT of the same patients. The aim of the study was to see if 68Ga-DOTATATE PET/CT can detect more tumors with higher resolution and more exact localization, and then help to develop optimal treatment strategy and improves patient care.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 68Ga-DOTATATE, PET/CT scan | Experimental | Drug: 68Ga-DOTATATEWe will perform 68Ga-DOTATATE PET/CT scanning on subjects |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 68Ga-DOTATATEAlso: (68)Ga-DOTA-d-Phe(1),Tyr(3)-octreotateIntravenous 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) | Drug | 68Ga-DOTATATE, PET/CT scan |
Primary outcome
Number and location of lesions detected by 68GA-DOTATATE PET/CT compared to 99mTc-HYNIC-TOC SPECT/CT and/or 18F-FDG PET/CT
Time frame: 1 year
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 secondary outcome
Number of participants and kinds of adverse events as a measure of safety
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2017.
- Individual participant dataSharing planned: No
Related trials for Oncogenic Osteomalacia
Active, not recruitingObservational study
Tumor-induced Osteomalacia Disease Monitoring Program
Tumor-induced Osteomalacia (TIO)
Recruiting
Al18F-NOTA-LM3 PET/CT in Patients With TIO
Tumor-Induced Osteomalacia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fang Li, MD study chair
Department of Nuclear Medicine, Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing 68Ga-DOTATATE in people with Oncogenic Osteomalacia and Mesenchymal Tumor, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fang Li, MD (86-10-65295502, lifang@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and location of lesions detected by 68GA-DOTATATE PET/CT compared to 99mTc-HYNIC-TOC SPECT/CT and/or 18F-FDG PET/CT (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2017.