Adenocarcinoma of the ProstateSPECTNCT00608920
Single Photon Emission Computed Tomography (SPECT) Lymph Node Mapping
A study testing Single Photon Emission Computed Tomography (SPECT) in people with Adenocarcinoma of the Prostate, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The purpose of this study is to determine if the planning of radiation treatment of prostate cancer patient can be made more precise by comparing currently planning techniques to an imaging technique called SPECT. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Adenocarcinoma of the Prostate
- What is being tested?
- Single Photon Emission Computed Tomography (SPECT)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2007to Apr 2009
- Phase
- Interventional
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with biopsy proven adenocarcinoma of the prostate
- Patients with at least one of the following high risk clinical features at the time of presentation:
- Extra-prostatic extension (on palpation or radiographic imaging)
- PSA ≥ 20
- Gleason Score ≥ 8
- Patients scheduled to receive prostatic and pelvic IMRT with ACCULOC® target localization
Show all 9Show fewer
- Age > 18 years
- ECOG Performance Status ≤ 2
- Willing and able to sign informed consent document.-
Who cannot join
- History of radical prostatectomy
- History of prior pelvic radiation-
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: SPECT Lymph Node Mapping to Define Nodal Clinical Target Volume in Patients With Prostate Cancer
The purpose of this study is to determine if the planning of radiation treatment of prostate cancer patient can be made more precise by comparing currently planning techniques to an imaging technique called SPECT.
Read the detailed description
Single photon emission computed tomography (SPECT) uses radioactive tracers and a scanner to record data that a computer constructs into two- or three-dimensional images. A small amount of a radioactive drug is injected into the body and a scanner is used to make detailed images of areas inside the body where the radioactive material is taken up by the cells. Using a gamma camera (a special kind of scanner), we can create a better picture of the lymph node region. We will compare these pictures to images from your CT scan, to help plan your therapy.
The research in this study involves seeing if it is feasible to use SPECT scanning procedures for the purpose of planning your radiation treatment. We hope that doing so will allow us to more accurately and precisely plan radiation treatment to potential sites of cancer, and avoid delivering too much radiation to normal
- Conditions
- Adenocarcinoma of the Prostate
- Being tested
- Single Photon Emission Computed Tomography (SPECT)
- Keywords
- SPECT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single Photon Emission Computed Tomography (SPECT)Other
| Study group | Role | What they receive |
|---|---|---|
| SPECT lymph node mapping | Experimental | 1. Diagnostic pelvic CT
2. Nuclear tracer injection (Tc-99m) - same time as the ACCULOC seed implantation
3. CT simulation (2 hours after prostate markers are placed)
4. SPECT lymphoscintigraphy (first set of images 3-6 hours after injection and second set may be obtained 18-24 hours after injection) Receives: Other: Single Photon Emission Computed Tomography (SPECT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the feasibility of using SPECT-LM
Safety: The study will be feasible if no more than 80% of patients experience the following complications: infection requiring hospitalization or IV antibiotics, urinary retention requiring placement of a Foley catheter, moderate or severe allergic reaction to Tc99.
Efficacy: The study will be feasible if at least 80% of patients have at least one identifiable lymph node on SPECT-LM.
Measured: Completion of enrollment of all patients
Secondary outcomes (1)
Evaluate the extent to which current target delineation guidelines include actual lymphatic channels visualized on SPECT-LM in the study population.
- Greatest radial distance of lymphatic channel volume from vessel wall contour
- Fraction of lymphatic channel volume, normal tissue volume, and critical structure volumes included in radial expansions from vessel wall
Measured: Completion of enrollment of all patients
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2008 (estimated)
- Study startMar 2007
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenocarcinoma of the ProstateStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeff Michalski, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00608920
- Sponsor's protocol ID
- 06-0772
- Acronym
- SPECT
- Status last verified
- May 2013
- First submitted
- 2 Jan 2008
- Last updated
- 24 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SPECT Lymph Node Mapping to Define Nodal Clinical Target Volume in Patients With Prostate Cancer
- ClinicalTrials.gov ID
- NCT00608920
- Acronym / sponsor ID
- SPECT / 06-0772
- Conditions
- Adenocarcinoma of the Prostate
- Keywords
- SPECT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 6 Feb 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.
The purpose of this study is to determine if the planning of radiation treatment of prostate cancer patient can be made more precise by comparing currently planning techniques to an imaging technique called SPECT.
Detailed description
Single photon emission computed tomography (SPECT) uses radioactive tracers and a scanner to record data that a computer constructs into two- or three-dimensional images. A small amount of a radioactive drug is injected into the body and a scanner is used to make detailed images of areas inside the body where the radioactive material is taken up by the cells. Using a gamma camera (a special kind of scanner), we can create a better picture of the lymph node region. We will compare these pictures to images from your CT scan, to help plan your therapy.
The research in this study involves seeing if it is feasible to use SPECT scanning procedures for the purpose of planning your radiation treatment. We hope that doing so will allow us to more accurately and precisely plan radiation treatment to potential sites of cancer, and avoid delivering too much radiation to normal
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SPECT lymph node mapping | Experimental | Other: Single Photon Emission Computed Tomography (SPECT)1. Diagnostic pelvic CT 2. Nuclear tracer injection (Tc-99m) - same time as the ACCULOC seed implantation 3. CT simulation (2 hours after prostate markers are placed) 4. SPECT lymphoscintigraphy (first set of images 3-6 hours after injection and second set may be obtained 18-24 hours after injection) |
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)
- Patients with biopsy proven adenocarcinoma of the prostate
- Patients with at least one of the following high risk clinical features at the time of presentation:
- Extra-prostatic extension (on palpation or radiographic imaging)
- PSA ≥ 20
- Gleason Score ≥ 8
Key exclusion criteria (2 listed)
- History of radical prostatectomy
- History of prior pelvic radiation-
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 |
|---|---|---|
| Single Photon Emission Computed Tomography (SPECT) | Other | SPECT lymph node mapping |
Primary outcome
Determine the feasibility of using SPECT-LM
Time frame: Completion of enrollment of all patients
Safety: The study will be feasible if no more than 80% of patients experience the following complications: infection requiring hospitalization or IV antibiotics, urinary retention requiring placement of a Foley catheter, moderate or severe allergic reaction to Tc99. Efficacy: The study will be feasible if at least 80% of patients have at least one identifiable lymph node on SPECT-LM.
1 secondary outcome
Evaluate the extent to which current target delineation guidelines include actual lymphatic channels visualized on SPECT-LM in the study population.
Time frame: Completion of enrollment of all patients
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 24 May 2013.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink 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.
Jeff Michalski, M.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single Photon Emission Computed Tomography (SPECT) in people with Adenocarcinoma of the Prostate, run by Washington University School of Medicine 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 2 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 24 May 2013. 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?
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 the feasibility of using SPECT-LM (time frame: Completion of enrollment of all patients). 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 24 May 2013.