Bone MetastasesPET/CTNCT04080271
Role of Positron Emission Tomography/ Computed Tomography (PET/CT) and in Bone Metastases.
An observational study of Bone Metastases, run by Assiut University at 1 site in Egypt.
Trial summary
The aim of this study is to detect bone metastases by PET/CT examination in cancer patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bone Metastases
- What is being tested?
- 18F-FDG PET/CT
- Type of treatment
- Medical device
- How many people
- 66 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2019to 1 Dec 2021
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This study will recruit patients diagnosed with different types of tumors with wide range of age, suspected or diagnosed to have bone metastases, and referred to nuclear medicine unit to perform PET/CT examination, or resulted in to have bone metastases.
Who may be able to join
- patients diagnosed with different types of malignant tumor, suspected or diagnosed to have bone metastases and will do PET/CT examination
- patients diagnosed with different types of malignant tumor, with accidently discovered bone metastases during PET/CT examination.
- patients conscious to provide informed consent.
Who cannot join
- pregnant women.
- patients with blood sugar > 200 mg/dL.
- patients unable to sleep in a fixed position for 20 minutes.
- severely ill patients who aren't capable of complying with study procedures or comatose patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Positron Emission Tomography/Computed Tomography in Detecting Bone Metastases in Cancer Patients.
The aim of this study is to detect bone metastases by PET/CT examination in cancer patients.
Read the detailed description
Bone is a fertile soil for dissemination of metastatic tumor cells which can cause either osteolytic ( destructive) or osteoblastic (sclerotic) or mixed lesions in advanced cancer. Bone metastases are most common throughout the axial skeleton, this leads to major complications referred to as skeletal-related events (SREs), the most frequently are the need for radiotherapy and pathological fractures, associated with increase life morbidity and decrease overall survival.
Seeking accurate image modalities provides definite staging, determining the optimal strategy of treatment and precise evaluation to decrease the burden of complication.
PET/CT is superior than 2-dimensional planar providing a better image quality and enables quantitation of tumor metabolism. Acquisition and fusion of PET with CT also allow for localization and morphologic evaluation of abnormalities, leading to increased specificity. The National Comprehensive Cancer Network (NCCN) guideline recommended PET/CT imaging in cancers with high risk skeletal metastases, PET has advantage than CT in diagnosing osteolytic lesions; but combining PET with CT, increase the detection of osteoblastic lesions.
CT is recommended to evaluate structural integrity in revealing cortical integrity and the extent of structural destruction.
- Conditions
- Bone Metastases
- Being tested
- 18F-FDG PET/CT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-FDG PET/CTDevice
18F-fludeoxyglucose positron emission tomography/computed tomography
What is being measured
The primary outcome is the main question the study is designed to answer.
description of bone metastases detected by PET/CT in cancer patients.
Analysis of number, type and SUVmax of metastatic bony lesions detected by PET/CT in cancer patients.
Measured: one year
compare diagnostic performance of PET/CT, planar bone scintigraphy and SPECT/CT in detecting bone metastases
compare sensitivity, specificity, PPV,NPV and accuracy
Measured: one year
Secondary outcomes (1)
risk benefit of PET/CT examination in cancer patients
To evaluate risk benefit of PET/CT examination in cancer patients suspected to have bone metastasis.
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 posted6 Sep 2019
- Study start1 Nov 2019
- Primary completion1 Nov 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Bone MetastasesStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aalaa Wael Hussein, Assiut University
- Investigators
- Mohamed A. Mekkawy, Prof. Dr, Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04080271
- Sponsor's protocol ID
- PET/CT in bone metastases
- Acronym
- PET/CT
- Status last verified
- Jun 2022
- First submitted
- 4 Sep 2019
- Last updated
- 30 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Suva LJ, Washam C, Nicholas RW, Griffin RJ. Bone metastasis: mechanisms and therapeutic opportunities. Nat Rev Endocrinol. 2011 Apr;7(4):208-18. doi: 10.1038/nrendo.2010.227. Epub 2011 Jan 4.
PubMed 21200394Choi J, Raghavan M. Diagnostic imaging and image-guided therapy of skeletal metastases. Cancer Control. 2012 Apr;19(2):102-12. doi: 10.1177/107327481201900204.
PubMed 22487972Coleman R, Body JJ, Aapro M, Hadji P, Herrstedt J; ESMO Guidelines Working Group. Bone health in cancer patients: ESMO Clinical Practice Guidelines. Ann Oncol. 2014 Sep;25 Suppl 3:iii124-37. doi: 10.1093/annonc/mdu103. Epub 2014 Apr 29.
PubMed 24782453Crawford ED, Stone NN, Yu EY, Koo PJ, Freedland SJ, Slovin SF, Gomella LG, Berger ER, Keane TE, Sieber P, Shore ND, Petrylak DP; Prostate Cancer Radiographic Assessments for Detection of Advanced Recurrence (RADAR) Group. Challenges and recommendations for early identification of metastatic disease in prostate cancer. Urology. 2014 Mar;83(3):664-9. doi: 10.1016/j.urology.2013.10.026. Epub 2014 Jan 8.
PubMed 24411213Rosenthal DI. Radiologic diagnosis of bone metastases. Cancer. 1997 Oct 15;80(8 Suppl):1595-607. doi: 10.1002/(sici)1097-0142(19971015)80:8+3.3.co;2-z.
PubMed 9362427National Comprehensive Cancer Network (NCCN) Breast Cancer NCCN Practice Guidelines in Oncology. Fort Washington, PA:NCCN. 2014. Ver. 2.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Positron Emission Tomography/Computed Tomography in Detecting Bone Metastases in Cancer Patients.
- ClinicalTrials.gov ID
- NCT04080271
- Acronym / sponsor ID
- PET/CT / PET/CT in bone metastases
- Conditions
- Bone Metastases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 6 Sep 2019 (actual)
- 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.
The aim of this study is to detect bone metastases by PET/CT examination in cancer patients.
Detailed description
Bone is a fertile soil for dissemination of metastatic tumor cells which can cause either osteolytic ( destructive) or osteoblastic (sclerotic) or mixed lesions in advanced cancer. Bone metastases are most common throughout the axial skeleton, this leads to major complications referred to as skeletal-related events (SREs), the most frequently are the need for radiotherapy and pathological fractures, associated with increase life morbidity and decrease overall survival.
Seeking accurate image modalities provides definite staging, determining the optimal strategy of treatment and precise evaluation to decrease the burden of complication.
PET/CT is superior than 2-dimensional planar providing a better image quality and enables quantitation of tumor metabolism. Acquisition and fusion of PET with CT also allow for localization and morphologic evaluation of abnormalities, leading to increased specificity. The National Comprehensive Cancer Network (NCCN) guideline recommended PET/CT imaging in cancers with high risk skeletal metastases, PET has advantage than CT in diagnosing osteolytic lesions; but combining PET with CT, increase the detection of osteoblastic lesions.
CT is recommended to evaluate structural integrity in revealing cortical integrity and the extent of structural destruction.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study will recruit patients diagnosed with different types of tumors with wide range of age, suspected or diagnosed to have bone metastases, and referred to nuclear medicine unit to perform PET/CT examination, or resulted in to have bone metastases.
Key inclusion criteria (3 listed)
- patients diagnosed with different types of malignant tumor, suspected or diagnosed to have bone metastases and will do PET/CT examination
- patients diagnosed with different types of malignant tumor, with accidently discovered bone metastases during PET/CT examination.
- patients conscious to provide informed consent.
Key exclusion criteria (4 listed)
- pregnant women.
- patients with blood sugar > 200 mg/dL.
- patients unable to sleep in a fixed position for 20 minutes.
- severely ill patients who aren't capable of complying with study procedures or comatose patients.
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 |
|---|---|---|
| 18F-FDG PET/CT18F-fludeoxyglucose positron emission tomography/computed tomography | Device | – |
Primary outcome
description of bone metastases detected by PET/CT in cancer patients.
Time frame: one year
Analysis of number, type and SUVmax of metastatic bony lesions detected by PET/CT in cancer patients.
compare diagnostic performance of PET/CT, planar bone scintigraphy and SPECT/CT in detecting bone metastases
Time frame: one year
compare sensitivity, specificity, PPV,NPV and accuracy
1 secondary outcome
risk benefit of PET/CT examination in cancer patients
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2022.
- Background: PubMed 21200394Suva LJ, Washam C, Nicholas RW, Griffin RJ. Bone metastasis: mechanisms and therapeutic opportunities. Nat Rev Endocrinol. 2011 Apr;7(4):208-18. doi: 10.1038/nrendo.2010.227. Epub 2011 Jan 4.
- Background: PubMed 22487972Choi J, Raghavan M. Diagnostic imaging and image-guided therapy of skeletal metastases. Cancer Control. 2012 Apr;19(2):102-12. doi: 10.1177/107327481201900204.
- Background: PubMed 24782453Coleman R, Body JJ, Aapro M, Hadji P, Herrstedt J; ESMO Guidelines Working Group. Bone health in cancer patients: ESMO Clinical Practice Guidelines. Ann Oncol. 2014 Sep;25 Suppl 3:iii124-37. doi: 10.1093/annonc/mdu103. Epub 2014 Apr 29.
- Background: PubMed 24411213Crawford ED, Stone NN, Yu EY, Koo PJ, Freedland SJ, Slovin SF, Gomella LG, Berger ER, Keane TE, Sieber P, Shore ND, Petrylak DP; Prostate Cancer Radiographic Assessments for Detection of Advanced Recurrence (RADAR) Group. Challenges and recommendations for early identification of metastatic disease in prostate cancer. Urology. 2014 Mar;83(3):664-9. doi: 10.1016/j.urology.2013.10.026. Epub 2014 Jan 8.
- Background: PubMed 9362427Rosenthal DI. Radiologic diagnosis of bone metastases. Cancer. 1997 Oct 15;80(8 Suppl):1595-607. doi: 10.1002/(sici)1097-0142(19971015)80:8+3.3.co;2-z.
- BackgroundNational Comprehensive Cancer Network (NCCN) Breast Cancer NCCN Practice Guidelines in Oncology. Fort Washington, PA:NCCN. 2014. Ver. 2.
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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.
Mohamed A. Mekkawy, Prof. Dr study chair
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Metastases, run by Assiut University at 1 site in Egypt.
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 4 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: finished, as of the sponsor's last update on 30 Jun 2022. 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 Egypt. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
description of bone metastases detected by PET/CT in cancer patients. (time frame: one year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04080271, which also lists 6 linked publications.
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 30 Jun 2022.