Unspecified Adult Solid Tumor, Protocol SpecificEarly Phase 1NCT00816335
Fludeoxyglucose F 18 PET/CT Imaging in Finding Cancer in Patients Undergoing Surgery for Solid Tumors
A Early Phase 1 study testing PET/CT scan, 18F-FDG Injection and Preoperative 18F-FDG PET/CT Scan in people with Unspecified Adult Solid Tumor, Protocol Specific, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial summary
The purpose of this pilot study is to evaluate a combined and integrated technological approach of 18F-FDG-directed perioperative PET/CT imaging and intraoperative handheld gamma probe detection of known and occult disease in patients undergoing surgery for solid malignancies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- PET/CT scan, 18F-FDG Injection and Preoperative 18F-FDG PET/CT Scan
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Aug 2011
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be 18 years of age or older.
- Patients must either have a histologic-confirmed solid malignancy or have a suspected solid malignancy which has required a diagnostic preoperative PET/CT scan or for which a diagnostic preoperative PET/CT scan has been recommended
- Patients must clinically have been determined to be a candidate for the indicated surgical procedure.
- Patients may have had prior surgery and/or chemotherapy with no limit to the number of prior therapeutic procedures or chemotherapeutic regimens.
- Patients must have a performance status of 0, 1 or 2 by ECOG standards.
- Patients must give written informed consent, including consent to have IV line placed for 18F-FDG administration.
- Females of childbearing age must have a negative pregnancy test (by Beta HCG qualitative analysis), must have had a history of a surgical sterilization, or must give history of no menses in past twelve months.
- Fasting blood sugar less than 200 mg/dl.
Who cannot join
- Any patient with active CNS tumor involvement.
- Any patient who is pregnant or lactating.
- Any patient with a body size and habitus that is determined to prohibit use of the diagnostic equipment.
- Any patient with a tumor burden that is determined to be so great (as determined by preoperative PET/CT scanning or intraoperative findings) that further surgery is not advised.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Medical Center
Columbus, Ohio, 43210-1240
About this study
Official title: Pilot Study Evaluating a Combined and Integrated Technological Approach of F-18-FDG-Directed Perioperative PET/CT Imaging and Intraoperative Handheld Gamma Prove Detection of Known and Occult Disease in Patients Undergoing Surgery for Solid Malignancies
The purpose of this pilot study is to evaluate a combined and integrated technological approach of 18F-FDG-directed perioperative PET/CT imaging and intraoperative handheld gamma probe detection of known and occult disease in patients undergoing surgery for solid malignancies.
Read the detailed description
OBJECTIVES:
- To determine if the perioperative PET/CT imaging (consisting of preoperative PET/CT imaging, specimen PET/CT imaging, and postoperative PET/CT imaging) combined with intraoperative use of the handheld gamma probe is feasible during a surgical procedure to resect malignancy.
- To evaluate if perioperative PET/CT imaging can assist in intraoperatively localizing tumor and verify complete resection of disease.
- To evaluate intraoperative detection of tumor sites using a handheld gamma probe after preoperative injection of 18F-FDG combined with preoperative PET/CT imaging.
- To evaluate specimen PET/CT imaging using the preoperative 18F-FDG dose for detecting presence of tumor within the specimen and for assessing surgical margins.
- To evaluate specimen MRI imaging for detecting presence of tumor within remnant tissue of appropriately selected resected specimens and for assessing surgical margins.
- To evaluate standard pathology sampling with image guided pathology sampling (using specimen PET/CT imaging) in order to determine if sensitivity and accuracy of pathologic evaluation may be improved with PET/CT image guidance.
- To compare activity of surgical specimen samples in a well counter and correlate activity with pathologic findings and tumor burden in order to determine if the concepts in the previous two specific aims can be utilized to benefit patients treated at centers without access to PET/CT imaging equipment.
OUTLINE: Patients undergo pre- and postoperative fludeoxyglucose F 18 (^18FDG) PET/CT imaging. An intraoperative handheld gamma probe is used to detect ^18FDG-avid tissues. Resected specimens are assessed by ^18FDG PET imaging for intraoperative verification of complete tumor resection.
- Being tested
- PET/CT scan, 18F-FDG Injection, Preoperative 18F-FDG PET/CT Scan, 18F-FDG for patients with Bladder Cancer, Surgical Procedure
- Keywords
- unspecified adult solid tumor, protocol specific
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/CT scanProcedure or surgery
Also called Positron emission tomography, Computed tomography
For all patients undergoing a preoperative PET/CT scan on the day of surgery, at approximately 70 minutes post-injection of 18F-FDG, a diagnostic whole body PET/CT scan will be obtained on a Siemens Biograph 16 PET/CT scanner (Siemens, Knoxville, TN).
18F-FDG InjectionDrug
Also called Fludeoxyglucose, fdg
Patients undergoing a preoperative PET/CT scan the day of surgery, are required to have fasted for at least 4 hours prior to the anticipated preoperative PET/CT scan. Patients participating in this pilot study (whether they have had their preoperative PET/CT scan prior to the day of surgery or whether they are having their preoperative PET/CT scan on the day of surgery) will receive a preoperative IV injection into a peripheral vein of 15 mCi of 18FFDG at time interval of approximately 60 to 180 minutes prior to anticipated time of surgery.
Preoperative 18F-FDG PET/CT ScanProcedure or surgery
Also called Fludeoxyglucose, fdg, Positron emission tomography, Computed tomography
Patients undergoing preoperative PET/CT scan day of surgery, at approximately 70 minutes post-injection of 18F-FDG, a diagnostic whole body PET/CT scan will be obtained. PET imaging will immediately be preceded by noncontrast transmission CT (for attenuation correction and anatomic correlation purposes) and will be obtained from the base of the skull to the mid thighs. Bed positions will be scanned for 3 minutes each, moving the patient through the scanner in a craniocaudal direction. Once the preoperative PET/CT scan is acquired, images will be reviewed by the nuclear medicine physician and the surgeon.
18F-FDG for patients with Bladder CancerDrug
Also called Fludeoxyglucose, fdg
Elimination of 18F-FDG by the urinary system and accumulation in the bladder impacts the differentiation between residual 18F-FDG in the bladder and activity in tumor and adjacent lymph nodes. For patients with bladder cancer, the urinary catheter routinely placed in the operating room will be inserted in the Ambulatory Surgery Unit (ASU) by the urologist on-service or the urology research nurse. A 3-way Foley catheter will be placed for continuous bladder irrigation with Normal Saline (0.9%) initiated in ASU and will continue for the duration of the imaging procedure at a standard rate of 10cc/minute. The urology research nurse will transport the patient to and from the PET/CT area and monitor the continuous bladder irrigation during the imaging session.
Surgical ProcedureProcedure or surgery
Previously determined operative procedure based on type of solid malignancy. Factors include extent and location of disease, physiologic status of patient intraoperatively, any technical considerations influenced by anatomic constraints, and a risk: benefit analysis of proposed procedure. The decision to proceed with resection on these factors, and will constantly re-evaluate during resection to ensure patient well-being, both short and long term, is foremost consideration. Evaluation of extent of disease during surgical exploration will include inspection and palpation of entire area being evaluated. Tissue that is highly suspicious for involvement with metastatic disease that alters the surgical decision making plan of resection will be biopsied or resected for histologic confirmation if feasible and safe. If patient is found to have resectable disease, deemed safe patient, surgeon will continue and proceed with definitive surgical resection with assistance of handheld gamma probe.
Specimen PET/CT ScanProcedure or surgery
Resected surgical specimen will be placed on top of paraffin block. Digital photos of the specimen will be obtained for visual correlation of specimen placement on paraffin block. Two bed position 10 minute specimen PET/CT scan will be performed on surgical specimen. If remnant tissue is available, a second image maybe acquired via MRI. Images will be processed and reviewed for quality and presence or absence of hypermetabolic foci and correlated with anatomical information provided by CT and MRI imaging that were originally noted in the preoperative clinical PET/CT scan. During the time when the excised surgical specimens are transported to radiology for specimen PET/CT scanning, additional evaluation of these ex-vivo specimens with other tumor detection devices may be undertaken. Specimen will then be transported back to the operating room in order to be sent to and processed by surgical pathology for standard pathologic evaluation.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | F-FDG-directed surgery for known or suspected malignancy using gamma detection probes. Receives: Procedure: PET/CT scan; Drug: 18F-FDG Injection; Procedure: Preoperative 18F-FDG PET/CT Scan; Drug: 18F-FDG for patients with Bladder Cancer; Procedure: Surgical Procedure; Procedure: Specimen PET/CT Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine perioperative PET/CT imaging combined with intraoperative use of handheld gamma probe is feasible during surgical procedure to resect malignancy.
Measured: up to five years
Secondary outcomes (6)
Evaluate if perioperative PET/CT imaging can assist in intraoperatively localizing tumor and verify resection of disease.
Measured: up to five years
Evaluate intraoperative detection of tumor sites using a handheld gamma probe after preoperative injection of 18F-FDG combined with preoperative PET/CT imaging.
Measured: up to five years
Evaluate specimen PET/CT imaging using the preoperative 18F-FDG dose for detecting presence of tumor within the specimen and for assessing surgical margins.
Measured: up to five years
Evaluate specimen MRI imaging for detecting presence of tumor within remnant tissue of appropriately selected resected specimens and for assessing surgical margins.
Measured: up to five years
Evaluate standard pathology sampling with image guided pathology sampling (using specimen PET/CT imaging) in order to determine if sensitivity and accuracy of pathologic evaluation may be improved with PET/CT image guidance.
Measured: up to five years
Compare activity of surgical specimen samples with pathologic findings and tumor burden in order to determine if the concepts in previous two specific aims can be utilized to benefit patients treated at centers without access to PET/CT imaging equipment.
Measured: up to five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2009 (estimated)
- Study startOct 2008
- Primary completionAug 2011
- Study completionAug 2011
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 Unspecified Adult Solid Tumor, Protocol SpecificStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe 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
- 65 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephen Povoski, Ohio State University Comprehensive Cancer Center
- Investigators
- Stephen P. Povoski, MD, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00816335
- Sponsor's protocol ID
- OSU-08031
- Other IDs
- NCI-2012-00958
- Status last verified
- Mar 2016
- First submitted
- 31 Dec 2008
- Last updated
- 4 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Povoski SP, Chapman GJ, Murrey DA Jr, Lee R, Martin EW Jr, Hall NC. Intraoperative detection of (1)(8)F-FDG-avid tissue sites using the increased probe counting efficiency of the K-alpha probe design and variance-based statistical analysis with the three-sigma criteria. BMC Cancer. 2013 Mar 4;13:98. doi: 10.1186/1471-2407-13-98.
PubMed 23496877
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Evaluating a Combined and Integrated Technological Approach of F-18-FDG-Directed Perioperative PET/CT Imaging and Intraoperative Handheld Gamma Prove Detection of Known and Occult Disease in Patients Undergoing Surgery for Solid Malignancies
- ClinicalTrials.gov ID
- NCT00816335
- Acronym / sponsor ID
- OSU-08031
- Keywords
- unspecified adult solid tumor, protocol specific
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 1 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 purpose of this pilot study is to evaluate a combined and integrated technological approach of 18F-FDG-directed perioperative PET/CT imaging and intraoperative handheld gamma probe detection of known and occult disease in patients undergoing surgery for solid malignancies.
Detailed description
OBJECTIVES:
- To determine if the perioperative PET/CT imaging (consisting of preoperative PET/CT imaging, specimen PET/CT imaging, and postoperative PET/CT imaging) combined with intraoperative use of the handheld gamma probe is feasible during a surgical procedure to resect malignancy.
- To evaluate if perioperative PET/CT imaging can assist in intraoperatively localizing tumor and verify complete resection of disease.
- To evaluate intraoperative detection of tumor sites using a handheld gamma probe after preoperative injection of 18F-FDG combined with preoperative PET/CT imaging.
- To evaluate specimen PET/CT imaging using the preoperative 18F-FDG dose for detecting presence of tumor within the specimen and for assessing surgical margins.
- To evaluate specimen MRI imaging for detecting presence of tumor within remnant tissue of appropriately selected resected specimens and for assessing surgical margins.
- To evaluate standard pathology sampling with image guided pathology sampling (using specimen PET/CT imaging) in order to determine if sensitivity and accuracy of pathologic evaluation may be improved with PET/CT image guidance.
- To compare activity of surgical specimen samples in a well counter and correlate activity with pathologic findings and tumor burden in order to determine if the concepts in the previous two specific aims can be utilized to benefit patients treated at centers without access to PET/CT imaging equipment.
OUTLINE: Patients undergo pre- and postoperative fludeoxyglucose F 18 (^18FDG) PET/CT imaging. An intraoperative handheld gamma probe is used to detect ^18FDG-avid tissues. Resected specimens are assessed by ^18FDG PET imaging for intraoperative verification of complete tumor resection.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Procedure: PET/CT scan, Drug: 18F-FDG Injection, Procedure: Preoperative 18F-FDG PET/CT Scan, Drug: 18F-FDG for patients with Bladder Cancer, Procedure: Surgical Procedure, Procedure: Specimen PET/CT ScanF-FDG-directed surgery for known or suspected malignancy using gamma detection probes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients must be 18 years of age or older.
- Patients must either have a histologic-confirmed solid malignancy or have a suspected solid malignancy which has required a diagnostic preoperative PET/CT scan or for which a diagnostic preoperative PET/CT scan has been recommended
- Patients must clinically have been determined to be a candidate for the indicated surgical procedure.
- Patients may have had prior surgery and/or chemotherapy with no limit to the number of prior therapeutic procedures or chemotherapeutic regimens.
- Patients must have a performance status of 0, 1 or 2 by ECOG standards.
Key exclusion criteria (4 listed)
- Any patient with active CNS tumor involvement.
- Any patient who is pregnant or lactating.
- Any patient with a body size and habitus that is determined to prohibit use of the diagnostic equipment.
- Any patient with a tumor burden that is determined to be so great (as determined by preoperative PET/CT scanning or intraoperative findings) that further surgery is not advised.
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 |
|---|---|---|
| PET/CT scanAlso: Positron emission tomography, Computed tomographyFor all patients undergoing a preoperative PET/CT scan on the day of surgery, at approximately 70 minutes post-injection of 18F-FDG, a diagnostic whole body PET/CT scan will be obtained on a Siemens Biograph 16 PET/CT scanner (Siemens, Knoxville, TN). | Procedure or surgery | Arm 1 |
| 18F-FDG InjectionAlso: Fludeoxyglucose, fdgPatients undergoing a preoperative PET/CT scan the day of surgery, are required to have fasted for at least 4 hours prior to the anticipated preoperative PET/CT scan. Patients participating in this pilot study (whether they have had their preoperative PET/CT scan prior to the day of surgery or whether they are having their preoperative PET/CT scan on the day of surgery) will receive a preoperative IV injection into a peripheral vein of 15 mCi of 18FFDG at time interval of approximately 60 to 180 minutes prior to anticipated time of surgery. | Drug | Arm 1 |
| Preoperative 18F-FDG PET/CT ScanAlso: Fludeoxyglucose, fdg, Positron emission tomography, Computed tomographyPatients undergoing preoperative PET/CT scan day of surgery, at approximately 70 minutes post-injection of 18F-FDG, a diagnostic whole body PET/CT scan will be obtained. PET imaging will immediately be preceded by noncontrast transmission CT (for attenuation correction and anatomic correlation purposes) and will be obtained from the base of the skull to the mid thighs. Bed positions will be scanned for 3 minutes each, moving the patient through the scanner in a craniocaudal direction. Once the preoperative PET/CT scan is acquired, images will be reviewed by the nuclear medicine physician and the surgeon. | Procedure or surgery | Arm 1 |
| 18F-FDG for patients with Bladder CancerAlso: Fludeoxyglucose, fdgElimination of 18F-FDG by the urinary system and accumulation in the bladder impacts the differentiation between residual 18F-FDG in the bladder and activity in tumor and adjacent lymph nodes. For patients with bladder cancer, the urinary catheter routinely placed in the operating room will be inserted in the Ambulatory Surgery Unit (ASU) by the urologist on-service or the urology research nurse. A 3-way Foley catheter will be placed for continuous bladder irrigation with Normal Saline (0.9%) initiated in ASU and will continue for the duration of the imaging procedure at a standard rate of 10cc/minute. The urology research nurse will transport the patient to and from the PET/CT area and monitor the continuous bladder irrigation during the imaging session. | Drug | Arm 1 |
| Surgical ProcedurePreviously determined operative procedure based on type of solid malignancy. Factors include extent and location of disease, physiologic status of patient intraoperatively, any technical considerations influenced by anatomic constraints, and a risk: benefit analysis of proposed procedure. The decision to proceed with resection on these factors, and will constantly re-evaluate during resection to ensure patient well-being, both short and long term, is foremost consideration. Evaluation of extent of disease during surgical exploration will include inspection and palpation of entire area being evaluated. Tissue that is highly suspicious for involvement with metastatic disease that alters the surgical decision making plan of resection will be biopsied or resected for histologic confirmation if feasible and safe. If patient is found to have resectable disease, deemed safe patient, surgeon will continue and proceed with definitive surgical resection with assistance of handheld gamma probe. | Procedure or surgery | Arm 1 |
| Specimen PET/CT ScanResected surgical specimen will be placed on top of paraffin block. Digital photos of the specimen will be obtained for visual correlation of specimen placement on paraffin block. Two bed position 10 minute specimen PET/CT scan will be performed on surgical specimen. If remnant tissue is available, a second image maybe acquired via MRI. Images will be processed and reviewed for quality and presence or absence of hypermetabolic foci and correlated with anatomical information provided by CT and MRI imaging that were originally noted in the preoperative clinical PET/CT scan. During the time when the excised surgical specimens are transported to radiology for specimen PET/CT scanning, additional evaluation of these ex-vivo specimens with other tumor detection devices may be undertaken. Specimen will then be transported back to the operating room in order to be sent to and processed by surgical pathology for standard pathologic evaluation. | Procedure or surgery | Arm 1 |
Primary outcome
Determine perioperative PET/CT imaging combined with intraoperative use of handheld gamma probe is feasible during surgical procedure to resect malignancy.
Time frame: up to five years
6 secondary outcomes
Evaluate if perioperative PET/CT imaging can assist in intraoperatively localizing tumor and verify resection of disease.
Time frame: up to five years
Evaluate intraoperative detection of tumor sites using a handheld gamma probe after preoperative injection of 18F-FDG combined with preoperative PET/CT imaging.
Time frame: up to five years
Evaluate specimen PET/CT imaging using the preoperative 18F-FDG dose for detecting presence of tumor within the specimen and for assessing surgical margins.
Time frame: up to five years
Evaluate specimen MRI imaging for detecting presence of tumor within remnant tissue of appropriately selected resected specimens and for assessing surgical margins.
Time frame: up to five years
Evaluate standard pathology sampling with image guided pathology sampling (using specimen PET/CT imaging) in order to determine if sensitivity and accuracy of pathologic evaluation may be improved with PET/CT image guidance.
Time frame: up to five years
Compare activity of surgical specimen samples with pathologic findings and tumor burden in order to determine if the concepts in previous two specific aims can be utilized to benefit patients treated at centers without access to PET/CT imaging equipment.
Time frame: up to five years
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 4 Apr 2016.
- Results publication: PubMed 23496877Povoski SP, Chapman GJ, Murrey DA Jr, Lee R, Martin EW Jr, Hall NC. Intraoperative detection of (1)(8)F-FDG-avid tissue sites using the increased probe counting efficiency of the K-alpha probe design and variance-based statistical analysis with the three-sigma criteria. BMC Cancer. 2013 Mar 4;13:98. doi: 10.1186/1471-2407-13-98.
- JameslineLink provided by the sponsor.
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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.
Stephen P. Povoski, MD principal investigator
Ohio State University Comprehensive Cancer Center
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 PET/CT scan, 18F-FDG Injection and Preoperative 18F-FDG PET/CT Scan in people with Unspecified Adult Solid Tumor, Protocol Specific, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
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 8 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 4 Apr 2016. 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 United States. 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?
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?
Determine perioperative PET/CT imaging combined with intraoperative use of handheld gamma probe is feasible during surgical procedure to resect malignancy. (time frame: up to five years). 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 NCT00816335, 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 4 Apr 2016.