Bone MetastasesNCT00824213
Pilot Project: Fast Whole-body Spect Scanning to Improve the Detection of Bone Metastases in Patients With Diagnosed Cancer
An observational study of Bone Metastases, run by University of British Columbia at 3 sites in Canada.
Trial summary
The investigators propose to investigate the performance of the image reconstruction software with resolution recovery correction for bone SPECT studies. The investigators estimate that in only 30 minutes, using this new technique of collimator de-blurring, one could perform a fully 3-dimensional SPECT whole-body bone… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bone Metastases
- How many people
- 50 participants
- Where
- 3 sitesCanada
- Study dates
- Jan 2009to 10 Aug 2016
- 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: Over the last 3-4 months, 60 anonymized patient studies were acquired using concurrent acquisition protocol with 20s, 15s, 10s, and 5s per view and with a total of 64 views (32 views/head). The data from these studies will be used to optimize the reconstruction process and establish the definitive reconstruction parameters to be used in the current study. We plan to accrue a total of 25 subjects with suspected bone metastases who will undergo planar bone scintigraphy, bone SPECT and a Na18F whole-body bone PET scan.
Who may be able to join
- Patients with a prior history of prostate cancer and
- clinically suspected bone metastases based on symptoms, radiological examinations or abnormal biochemistry results
Who cannot join
- Inability to consent to participate in the research study.
- Inability to lie supine for a period of at least 45 minutes.
- Inability to travel to the examination site to undergo the PET/CT examination.
- ECOG/WHO performance status ≥ 2
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Lions Gate Hospital
North Vancouver, British Columbia, V7L 2L7
British Columbia Cancer Agency
Vancouver, British Columbia, V5Z 1L3
Vancouver Coastal Health Research Institute
Vancouver, British Columbia, V5Z 3P1
About this study
The investigators propose to investigate the performance of the image reconstruction software with resolution recovery correction for bone SPECT studies. The investigators estimate that in only 30 minutes, using this new technique of collimator de-blurring, one could perform a fully 3-dimensional SPECT whole-body bone study, essentially obviating the necessity for doing planar bone studies.
In the scope of the proposed project, the investigators group aims to test the hypothesis that one can perform a Tc-99m whole-body SPECT study in the same time as a regular routine planar bone study, with greater localization accuracy, and greater lesion detection.
To establish a "gold standard" necessary to assess the performance of the SPECT bone scans, the investigators will compare number of malignant lesions detected in patients who are proven to have metastatic skeletal bone lesions on PET F-18 whole-body scans, with whole-body Tc-99m SPECT lesions. The investigators also propose to compare the detection of SPECT scans with standard planar bone scans. This will allow for two major comparisons (a) the accuracy of SPECT bone studies compared to planar bone studies, and (b) the accuracy of SPECT bone scans compared to F-18 PET studies. Most prior studies purporting to show the superiority of F-18 bone scans to Tc-99 bone scans were done only against either planar scans or a combination of planar scans and partial SPECT studies over the spine. We anticipate that F-18 bone scans, due to the higher counting statistics of PET agents, will show more lesions than SPECT, but the exact increase in sensitivity has never been compared to whole-body SPECT scans.
Read the detailed description
Introduction
Bone scintigraphy (e.g. "bone scan") with Tc-99m diphosphonates is one of the most common imaging radioisotope procedures in departments of nuclear medicine worldwide, with several thousand performed every year in a busy nuclear medicine service. Despite giving fast and accurate skeletal surveys in conditions ranging from metastatic cancer, to fractures, to infection, the technology has seen little change since the early 1970's. The Anger camera remains the instrument of choice for taking serial images of a patient's skeleton, and since the late 1970's SPECT (Single Photon Emission Computed Tomography) - essentially "nuclear CT imaging of 3-D distribution of radiotracer" has been added to improve contrast resolution and lesion placement.
Despite the known greater sensitivity of SPECT compared to planar bone nuclear medicine studies, SPECT is usually done only in limited patients due to time constraints. This is because a standard tomographic bone acquisition requires about 20 minutes, therefore it usually can only be performed over one body region such as the abdomen or chest.
Skeletal PET scanning with F-18 Fluoride has become popular since the introduction of multiple PET scanners for imaging cancer with F-18 FDG. It provides much higher count rates than traditional bone scans done with Tc-99m phosphates, and many authors have shown that it is the most sensitive imaging modality for detecting skeletal lesions. Indeed, several PET centers have proposed replacing the standard Tc-99m bone scan with F-18 PET scans. However the short half-life of F-18 makes this type of study practical only for PET centers within a short distance from a cyclotron. Furthermore, most PET scanners are usually fully occupied doing other types of diagnostic oncology studies, and the cost of the F-18 is currently not reimbursed for simple skeletal surveys.
Recently it has become feasible to dramatically shorten the time necessary for acquisition of a nuclear medicine SPECT study. This has occurred with the introduction of new image reconstruction software which includes resolution recovery correction (so called "collimator de-blurring"). Since this approach results in significant improvement of image resolution, many centers are currently looking at the feasibility of using this new technique to reduce imaging times. For example, its use has been investigated for nuclear cardiac scans with acquisition times shortened by half.
We propose to investigate the performance of the image reconstruction software with resolution recovery correction for bone SPECT studies. We estimate that in only 30 minutes, using this new technique of collimator de-blurring, one could perform a fully 3-dimensional SPECT whole-body bone study, essentially obviating the necessity for doing planar bone studies.
In the scope of the proposed project, our group aims to test the hypothesis that one can perform a Tc-99m whole-body SPECT study in the same time as a regular routine planar bone study, with greater localization accuracy, and greater lesion detection.
To establish a "gold standard" necessary to assess the performance of the SPECT bone scans, we will compare number of malignant lesions detected in patients who are proven to have metastatic skeletal bone lesions on PET F-18 whole-body scans, with whole-body Tc-99m SPECT lesions. We also propose to compare the detection of SPECT scans with standard planar bone scans. This will allow for two major comparisons (a) the accuracy of SPECT bone studies compared to planar bone studies, and (b) the accuracy of SPECT bone scans compared to F-18 PET studies. Most prior studies purporting to show the superiority of F-18 bone scans to Tc-99 bone scans were done only against either planar scans or a combination of planar scans and partial SPECT studies over the spine. We anticipate that F-18 bone scans, due to the higher counting statistics of PET agents, will show more lesions than SPECT, but the exact increase in sensitivity has never been compared to whole-body SPECT scans.
Objectives
- Evaluate the feasibility of implementing whole-body SPECT in routine practice with standard SPECT gamma cameras
- Evaluate the value of whole-body SPECT compared to whole-body planar studies for the detection of bone metastases
- Compare the results of state-of-the art whole-body SPECT skeleton surveys with state-of-the art whole-body Na18F PET whole-body bone surveys.
- Obtain preliminary data on the respective accuracy of planar bone scintigraphy, whole-body SPECT and Na18F PET/CT to plan future studies on the cost-effectiveness of these methods to improve prostate cancer staging.
Hypotheses
- A whole-body bone SPECT is more sensitive and specific than a conventional planar bone scan for the detection of bone metastases
- Whole-body bone SPECT is less sensitive than a whole-body bone PET but the lower sensitivity has minimal impact on the overall detection of bone metastases on a patient basis
Overall study design
This is an open phase II study designed to accumulate preliminary data on the relative diagnostic value of planar bone scintigraphy, whole-body bone SPECT and whole-body bone PET with sodium 18F-Fluoride. We plan to accrue a total of 25 subjects with suspected bone metastases who will undergo planar bone scintigraphy, bone SPECT and a Na18F whole-body bone PET scan.
Data analysis
All patients studies will be analyzed by 3 independent nuclear medicine readers, with number of lesions identified on planar scans being compared to number of lesions on non-Astonish SPECT bone scans and Astonish SPECT bone scans.
Each study will be scored by noting:
- number and localization of lesions detected
- level of certainty (1 = definitely malignant, 5= definitely benign)
- general visual quality of images (graded from 1 = poor to 5 = excellent)
The Na18F PET/CT bone study will serve as the reference gold-standard study against which the other acquisitions will be judged.
Statistical consideration
This is a pilot study which will provide preliminary data for further power calculations to estimate the study size needed to demonstrate a statistically significant improvement of whole-body SPECT compared to planar scintigraphy. With 25 subjects, we will have 82% of chance to demonstrate a statistically significant 30% difference in accuracy between planar scintigraphy and whole-body SPECT compared to the reference standard (PET/CT).
- Conditions
- Bone Metastases
- Keywords
- Whole Body SPECT imaging
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2009 (estimated)
- Study startJan 2009
- Primary completion10 Aug 2016
- Study completion10 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone MetastasesStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Investigators
- Anna Celler, PhD, Principal investigator, University of British ColumbiaPhilip Cohen, Study director, University of British ColumbiaFrancois Benard, Study director, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00824213
- Sponsor's protocol ID
- H08-01640
- Status last verified
- Mar 2017
- First submitted
- 14 Jan 2009
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Project: Fast Whole-body Spect Scanning to Improve the Detection of Bone Metastases in Patients With Diagnosed Cancer
- ClinicalTrials.gov ID
- NCT00824213
- Acronym / sponsor ID
- H08-01640
- Conditions
- Bone Metastases
- Keywords
- Whole Body SPECT imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- 10 Aug 2016 (actual)
- Study completion
- 10 Aug 2016 (actual)
- First posted
- 16 Jan 2009 (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.
The investigators propose to investigate the performance of the image reconstruction software with resolution recovery correction for bone SPECT studies. The investigators estimate that in only 30 minutes, using this new technique of collimator de-blurring, one could perform a fully 3-dimensional SPECT whole-body bone study, essentially obviating the necessity for doing planar bone studies.
In the scope of the proposed project, the investigators group aims to test the hypothesis that one can perform a Tc-99m whole-body SPECT study in the same time as a regular routine planar bone study, with greater localization accuracy, and greater lesion detection.
To establish a "gold standard" necessary to assess the performance of the SPECT bone scans, the investigators will compare number of malignant lesions detected in patients who are proven to have metastatic skeletal bone lesions on PET F-18 whole-body scans, with whole-body Tc-99m SPECT lesions. The investigators also propose to compare the detection of SPECT scans with standard planar bone scans. This will allow for two major comparisons (a) the accuracy of SPECT bone studies compared to planar bone studies, and (b) the accuracy of SPECT bone scans compared to F-18 PET studies. Most prior studies purporting to show the superiority of F-18 bone scans to Tc-99 bone scans were done only against either planar scans or a combination of planar scans and partial SPECT studies over the spine. We anticipate that F-18 bone scans, due to the higher counting statistics of PET agents, will show more lesions than SPECT, but the exact increase in sensitivity has never been compared to whole-body SPECT scans.
Detailed description
Introduction
Bone scintigraphy (e.g. "bone scan") with Tc-99m diphosphonates is one of the most common imaging radioisotope procedures in departments of nuclear medicine worldwide, with several thousand performed every year in a busy nuclear medicine service. Despite giving fast and accurate skeletal surveys in conditions ranging from metastatic cancer, to fractures, to infection, the technology has seen little change since the early 1970's. The Anger camera remains the instrument of choice for taking serial images of a patient's skeleton, and since the late 1970's SPECT (Single Photon Emission Computed Tomography) - essentially "nuclear CT imaging of 3-D distribution of radiotracer" has been added to improve contrast resolution and lesion placement.
Despite the known greater sensitivity of SPECT compared to planar bone nuclear medicine studies, SPECT is usually done only in limited patients due to time constraints. This is because a standard tomographic bone acquisition requires about 20 minutes, therefore it usually can only be performed over one body region such as the abdomen or chest.
Skeletal PET scanning with F-18 Fluoride has become popular since the introduction of multiple PET scanners for imaging cancer with F-18 FDG. It provides much higher count rates than traditional bone scans done with Tc-99m phosphates, and many authors have shown that it is the most sensitive imaging modality for detecting skeletal lesions. Indeed, several PET centers have proposed replacing the standard Tc-99m bone scan with F-18 PET scans. However the short half-life of F-18 makes this type of study practical only for PET centers within a short distance from a cyclotron. Furthermore, most PET scanners are usually fully occupied doing other types of diagnostic oncology studies, and the cost of the F-18 is currently not reimbursed for simple skeletal surveys.
Recently it has become feasible to dramatically shorten the time necessary for acquisition of a nuclear medicine SPECT study. This has occurred with the introduction of new image reconstruction software which includes resolution recovery correction (so called "collimator de-blurring"). Since this approach results in significant improvement of image resolution, many centers are currently looking at the feasibility of using this new technique to reduce imaging times. For example, its use has been investigated for nuclear cardiac scans with acquisition times shortened by half.
We propose to investigate the performance of the image reconstruction software with resolution recovery correction for bone SPECT studies. We estimate that in only 30 minutes, using this new technique of collimator de-blurring, one could perform a fully 3-dimensional SPECT whole-body bone study, essentially obviating the necessity for doing planar bone studies.
In the scope of the proposed project, our group aims to test the hypothesis that one can perform a Tc-99m whole-body SPECT study in the same time as a regular routine planar bone study, with greater localization accuracy, and greater lesion detection.
To establish a "gold standard" necessary to assess the performance of the SPECT bone scans, we will compare number of malignant lesions detected in patients who are proven to have metastatic skeletal bone lesions on PET F-18 whole-body scans, with whole-body Tc-99m SPECT lesions. We also propose to compare the detection of SPECT scans with standard planar bone scans. This will allow for two major comparisons (a) the accuracy of SPECT bone studies compared to planar bone studies, and (b) the accuracy of SPECT bone scans compared to F-18 PET studies. Most prior studies purporting to show the superiority of F-18 bone scans to Tc-99 bone scans were done only against either planar scans or a combination of planar scans and partial SPECT studies over the spine. We anticipate that F-18 bone scans, due to the higher counting statistics of PET agents, will show more lesions than SPECT, but the exact increase in sensitivity has never been compared to whole-body SPECT scans.
Objectives
- Evaluate the feasibility of implementing whole-body SPECT in routine practice with standard SPECT gamma cameras
- Evaluate the value of whole-body SPECT compared to whole-body planar studies for the detection of bone metastases
- Compare the results of state-of-the art whole-body SPECT skeleton surveys with state-of-the art whole-body Na18F PET whole-body bone surveys.
- Obtain preliminary data on the respective accuracy of planar bone scintigraphy, whole-body SPECT and Na18F PET/CT to plan future studies on the cost-effectiveness of these methods to improve prostate cancer staging.
Hypotheses
- A whole-body bone SPECT is more sensitive and specific than a conventional planar bone scan for the detection of bone metastases
- Whole-body bone SPECT is less sensitive than a whole-body bone PET but the lower sensitivity has minimal impact on the overall detection of bone metastases on a patient basis
Overall study design
This is an open phase II study designed to accumulate preliminary data on the relative diagnostic value of planar bone scintigraphy, whole-body bone SPECT and whole-body bone PET with sodium 18F-Fluoride. We plan to accrue a total of 25 subjects with suspected bone metastases who will undergo planar bone scintigraphy, bone SPECT and a Na18F whole-body bone PET scan.
Data analysis
All patients studies will be analyzed by 3 independent nuclear medicine readers, with number of lesions identified on planar scans being compared to number of lesions on non-Astonish SPECT bone scans and Astonish SPECT bone scans.
Each study will be scored by noting:
- number and localization of lesions detected
- level of certainty (1 = definitely malignant, 5= definitely benign)
- general visual quality of images (graded from 1 = poor to 5 = excellent)
The Na18F PET/CT bone study will serve as the reference gold-standard study against which the other acquisitions will be judged.
Statistical consideration
This is a pilot study which will provide preliminary data for further power calculations to estimate the study size needed to demonstrate a statistically significant improvement of whole-body SPECT compared to planar scintigraphy. With 25 subjects, we will have 82% of chance to demonstrate a statistically significant 30% difference in accuracy between planar scintigraphy and whole-body SPECT compared to the reference standard (PET/CT).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Over the last 3-4 months, 60 anonymized patient studies were acquired using concurrent acquisition protocol with 20s, 15s, 10s, and 5s per view and with a total of 64 views (32 views/head). The data from these studies will be used to optimize the reconstruction process and establish the definitive reconstruction parameters to be used in the current study. We plan to accrue a total of 25 subjects with suspected bone metastases who will undergo planar bone scintigraphy, bone SPECT and a Na18F whole-body bone PET scan.
Key inclusion criteria (2 listed)
- Patients with a prior history of prostate cancer and
- clinically suspected bone metastases based on symptoms, radiological examinations or abnormal biochemistry results
Key exclusion criteria (4 listed)
- Inability to consent to participate in the research study.
- Inability to lie supine for a period of at least 45 minutes.
- Inability to travel to the examination site to undergo the PET/CT examination.
- ECOG/WHO performance status ≥ 2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 3 Mar 2017.
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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.
Anna Celler, PhD principal investigator
University of British Columbia
Philip Cohen study director
University of British Columbia
Francois Benard study director
University of British Columbia
3 sites 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 University of British Columbia at 3 sites in Canada.
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 2 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 3 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. 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.
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 3 Mar 2017.