NeoplasmsNCT00725387
Combined F-18 NaF and F-18 FDG PET/CT for Evaluation of Malignancy
An observational study of Neoplasms, run by Stanford University at 5 sites in 5 countries.
Trial summary
Fluorine-18 Fluorodeoxyglucose (F-18 FDG) PET/CT is established as a powerful imaging tool for cancer detection and monitoring response to therapy. Sodium Fluorine-18 (F-18) was used in the 1970s for bone scanning and can be used as a skeletal tracer in current PET/CT scanners. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- How many people
- 214 participants
- Where
- 5 sitesin 5 countries
- Study dates
- Aug 2007to Jun 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients must be referred for evaluation of bone metastases.
Who may be able to join
- Patients older than 18-year-old, diagnosed with cancer
- Patients must understand and voluntarily sign an Informed Consent form after the contents have been fully explained to them
Who cannot join
- Patients who cannot complete a PET/CT scan
- Pregnant women
- Healthy volunteers
- Patients participating in other research studies
- The subjects will not be paid to participate in this protocol. No costs will be charged to the subjects.
Trial locations and contacts
5 sites in 5 countries.
5 sites in 5 countries
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Fluorine-18 Fluorodeoxyglucose (F-18 FDG) PET/CT is established as a powerful imaging tool for cancer detection and monitoring response to therapy. Sodium Fluorine-18 (F-18) was used in the 1970s for bone scanning and can be used as a skeletal tracer in current PET/CT scanners. The combined administration of F-18 and F-18 FDG in a single PET/CT scan for cancer detection was not attempted to date. We hope to learn what is the best approach for detection of cancer and thus to improve cancer treatment.
- Conditions
- Neoplasms
- Medical subject headings
- Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of patients with evidence of new lesions on combined F-18/F-18 FDG PET/CT.
Measured: not defined
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2008 (estimated)
- Study startAug 2007
- Primary completionDec 2018
- Study completionJun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- More trials run by Stanford 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrei Iagaru M.D, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00725387
- Sponsor's protocol ID
- VAR0024
- Other IDs
- 98043, SU-07232008-1266
- Status last verified
- Sep 2019
- First submitted
- 28 Jul 2008
- Last updated
- 18 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Iagaru A, Mittra E, Mosci C, Dick DW, Sathekge M, Prakash V, Iyer V, Lapa P, Isidoro J, de Lima JM, Gambhir SS. Combined 18F-fluoride and 18F-FDG PET/CT scanning for evaluation of malignancy: results of an international multicenter trial. J Nucl Med. 2013 Feb;54(2):176-83. doi: 10.2967/jnumed.112.108803. Epub 2012 Dec 14.
PubMed 23243299
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined F-18 NaF and F-18 FDG PET/CT for Evaluation of Malignancy
- ClinicalTrials.gov ID
- NCT00725387
- Acronym / sponsor ID
- VAR0024
- Conditions
- Neoplasms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Aug 2007 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 30 Jul 2008 (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.
Fluorine-18 Fluorodeoxyglucose (F-18 FDG) PET/CT is established as a powerful imaging tool for cancer detection and monitoring response to therapy. Sodium Fluorine-18 (F-18) was used in the 1970s for bone scanning and can be used as a skeletal tracer in current PET/CT scanners. The combined administration of F-18 and F-18 FDG in a single PET/CT scan for cancer detection was not attempted to date. We hope to learn what is the best approach for detection of cancer and thus to improve cancer treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients must be referred for evaluation of bone metastases.
Key inclusion criteria (2 listed)
- Patients older than 18-year-old, diagnosed with cancer
- Patients must understand and voluntarily sign an Informed Consent form after the contents have been fully explained to them
Key exclusion criteria (5 listed)
- Patients who cannot complete a PET/CT scan
- Pregnant women
- Healthy volunteers
- Patients participating in other research studies
- The subjects will not be paid to participate in this protocol. No costs will be charged to the subjects.
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
Percent of patients with evidence of new lesions on combined F-18/F-18 FDG PET/CT.
Time frame: not defined
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 18 Sep 2019.
- Derived from this study: PubMed 23243299Iagaru A, Mittra E, Mosci C, Dick DW, Sathekge M, Prakash V, Iyer V, Lapa P, Isidoro J, de Lima JM, Gambhir SS. Combined 18F-fluoride and 18F-FDG PET/CT scanning for evaluation of malignancy: results of an international multicenter trial. J Nucl Med. 2013 Feb;54(2):176-83. doi: 10.2967/jnumed.112.108803. Epub 2012 Dec 14.
- Individual participant dataSharing planned: No
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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.
Andrei Iagaru M.D principal investigator
Stanford University
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neoplasms, run by Stanford University at 5 sites in 5 countries.
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 5 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 18 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Denmark, India, Portugal, South Africa. 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?
Percent of patients with evidence of new lesions on combined F-18/F-18 FDG PET/CT. (time frame: not defined). 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 NCT00725387, which also lists 1 linked publication.
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 18 Sep 2019.