Prostate CancerNCT01008969
Feasibility of Using SPECT/CT Imaging to Map Lymphatic Drainage Patterns in Prostate Cancer Patients
A study testing SPECT-CT imaging in people with Prostate Cancer, run by University of California, San Francisco at 1 site in United States.
Trial summary
The purpose of this study is to develop a practice procedure for lymphatic drainage mapping with the intent of providing a new tool that could potentially be used for radiation treatment planning. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- SPECT-CT imaging
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Dec 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male
- Age ≥ 18 years
- Diagnosis of definitive high-risk prostate cancer
- Clinically eligible and scheduled for definitive IMRT treatment with pelvic lymph nodal radiation (not a study procedure)
- At least one of the following risk factors:
- Pathologically confirmed pelvic nodal involvement;
Show all 9Show fewer
- Enlarged pelvic lymph nodes (greater than 1 cm in the short axis) visible on CT or MRI images, or
- Greater than 15% risk of lymph node involvement calculated using the equation: Risk of positive nodes (%) = (2/3) prostate specific antigen (PSA) + [(Gleason score - 6)] × 10]. This formula is used to estimate the pathologic stage of prostate cancer with preoperative prostate specific antigen (PSA) and Gleason score, and adopted by many radiation oncology clinics, including our own radiation oncology physicians.
- Ability to give written informed consent and willingness to comply with the requirements of the protocol
Who cannot join
- Any condition that compromises compliance with the objectives and procedures of this protocol, as judged by the principal investigator
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94115
About this study
Official title: Practice Procedure for 99mTc-Sulfur Nanocolloid Lymphatic Drainage Mapping in Prostate Cancer Using SPECT-CT (Single Photon Emission Computed Tomography / Computed Tomography)
The purpose of this study is to develop a practice procedure for lymphatic drainage mapping with the intent of providing a new tool that could potentially be used for radiation treatment planning. High-risk prostate cancer patients who are scheduled to be treated with intensity-modulated radiotherapy (IMRT) may be eligible to enroll in this study. 99mTc-sulfur nanocolloid, a radiopharmaceutical ("tracer") will be injected by a urologist using transrectal ultrasound guidance (TRUS)at the UCSF Urology Clinic. Participants will then undergo SPECT/CT imaging at the UCSF Nuclear Medicine Clinic. This study will evaluate the feasibility of transporting patients to the Nuclear Medicine Clinic for imaging within 1-3 hours after administration of 99mTc-sulfur nanocolloid.
Read the detailed description
The entire study procedure involves 1) preparation of 99mTc-sulfur nanocolloid, 2) administration of 99mTc-sulfur nanocolloid with transrectal ultrasound guidance, 3) transfer of the patient to the Nuclear Medicine clinic for SPECT/CT (Infinia Hawkeye, GE Healthcare) imaging, and 4) tomographically capturing distributions of 99mTc-sulfur nanocolloid uptake in the patient's lymphatic drainage sites within a practical image acquisition time (1-3 h postinjection) considering the patient transit time between injection and imaging.
Administration of 99mTc-sulfur nanocolloid will be performed at the UCSF Urology clinic. The injection will be performed following the clinically accepted method that has been described by European investigators. 99mTc-sulfur nanocolloid imaging utilizes trace amounts of radioactivity. 100-200 MBq (2.7-5.4 mCi) of 99mTc-sulfur nanocolloid will be administered into two lobes of the prostate gland under transrectal ultrasound guidance with three fractions each into peripheral and central zone of the prostatic apex, mid portion, and base. 1% Lidocaine may be administered for local anesthesia per routine clinical protocol as deemed appropriate by the performing urologist.
The procedure will be considered feasible if the practice procedure (from injection to completion of imaging) is successfully implemented within 3 hours of injection (including patient transport time). Imaging will be considered successful if radiotracer is qualitatively detected within the prostate and local lymphatic system.
- Conditions
- Prostate Cancer
- Being tested
- SPECT-CT imaging
- Keywords
- Prostate, SPECT/CT
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPECT-CT imagingOther
SPECT/CT for 3-dimensional mapping of 99mTc-sulfur nanocolloid in order to identify personalized lymphatic drainage patterns
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Successfully Completed 99mTc-sulfur Nanocolloid SPECT/CT Within 3 Hours After Injection
Successful completion of 99mTc-sulfur nanocolloid SPECT/CT means that the images were obtained within 3 hours, and the images showed patients' lymphatic drainage.
Measured: 1 day
Secondary outcomes (1)
Percentage of Images With Detectable Sentinel Lymph Nodes (LNs) From 99mTc-sulfur Nanocolloid SPECT/CT Scans
There was only one arm for this study. All participants who had prostate cancer received 99mTc-sulfur nanocolloid injection and imaged by SPECT/CT within 3 hours of injection. The imaging studies qualitatively detected radiotracer distribution within the prostate and local lymphatic system. The detection of the radiotracer distribution was performed by experienced attending nuclear medicine physicians at UCSF. The qualitative detection includes visual lymph node uptake seen by SPECT scans overlaid on coregistered CT scans.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Youngho Seo, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01008969
- Sponsor's protocol ID
- CC085513, H46038-33934
- Status last verified
- Dec 2011
- First submitted
- 5 Nov 2009
- Last updated
- 2 Feb 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Practice Procedure for 99mTc-Sulfur Nanocolloid Lymphatic Drainage Mapping in Prostate Cancer Using SPECT-CT (Single Photon Emission Computed Tomography / Computed Tomography)
- ClinicalTrials.gov ID
- NCT01008969
- Acronym / sponsor ID
- CC085513, H46038-33934
- Conditions
- Prostate Cancer
- Keywords
- Prostate, SPECT/CT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 6 Nov 2009 (estimated)
- Results
- Posted 2 Feb 2012
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 study is to develop a practice procedure for lymphatic drainage mapping with the intent of providing a new tool that could potentially be used for radiation treatment planning. High-risk prostate cancer patients who are scheduled to be treated with intensity-modulated radiotherapy (IMRT) may be eligible to enroll in this study. 99mTc-sulfur nanocolloid, a radiopharmaceutical ("tracer") will be injected by a urologist using transrectal ultrasound guidance (TRUS)at the UCSF Urology Clinic. Participants will then undergo SPECT/CT imaging at the UCSF Nuclear Medicine Clinic. This study will evaluate the feasibility of transporting patients to the Nuclear Medicine Clinic for imaging within 1-3 hours after administration of 99mTc-sulfur nanocolloid.
Detailed description
The entire study procedure involves 1) preparation of 99mTc-sulfur nanocolloid, 2) administration of 99mTc-sulfur nanocolloid with transrectal ultrasound guidance, 3) transfer of the patient to the Nuclear Medicine clinic for SPECT/CT (Infinia Hawkeye, GE Healthcare) imaging, and 4) tomographically capturing distributions of 99mTc-sulfur nanocolloid uptake in the patient's lymphatic drainage sites within a practical image acquisition time (1-3 h postinjection) considering the patient transit time between injection and imaging.
Administration of 99mTc-sulfur nanocolloid will be performed at the UCSF Urology clinic. The injection will be performed following the clinically accepted method that has been described by European investigators. 99mTc-sulfur nanocolloid imaging utilizes trace amounts of radioactivity. 100-200 MBq (2.7-5.4 mCi) of 99mTc-sulfur nanocolloid will be administered into two lobes of the prostate gland under transrectal ultrasound guidance with three fractions each into peripheral and central zone of the prostatic apex, mid portion, and base. 1% Lidocaine may be administered for local anesthesia per routine clinical protocol as deemed appropriate by the performing urologist.
The procedure will be considered feasible if the practice procedure (from injection to completion of imaging) is successfully implemented within 3 hours of injection (including patient transport time). Imaging will be considered successful if radiotracer is qualitatively detected within the prostate and local lymphatic system.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male
- Age ≥ 18 years
- Diagnosis of definitive high-risk prostate cancer
- Clinically eligible and scheduled for definitive IMRT treatment with pelvic lymph nodal radiation (not a study procedure)
- At least one of the following risk factors:
Key exclusion criteria (1 listed)
- Any condition that compromises compliance with the objectives and procedures of this protocol, as judged by the principal investigator
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 |
|---|---|---|
| SPECT-CT imagingSPECT/CT for 3-dimensional mapping of 99mTc-sulfur nanocolloid in order to identify personalized lymphatic drainage patterns | Other | – |
Primary outcome
Percentage of Participants Successfully Completed 99mTc-sulfur Nanocolloid SPECT/CT Within 3 Hours After Injection
Time frame: 1 day
Successful completion of 99mTc-sulfur nanocolloid SPECT/CT means that the images were obtained within 3 hours, and the images showed patients' lymphatic drainage.
1 secondary outcome
Percentage of Images With Detectable Sentinel Lymph Nodes (LNs) From 99mTc-sulfur Nanocolloid SPECT/CT Scans
Time frame: 1 day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Youngho Seo, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SPECT-CT imaging in people with Prostate Cancer, run by University of California, San Francisco 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 9 inclusion and 1 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 2 Feb 2012. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Feb 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants Successfully Completed 99mTc-sulfur Nanocolloid SPECT/CT Within 3 Hours After Injection (time frame: 1 day). 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 2 Feb 2012.