Oropharynx CancerNCT05055206
Study of Lymphatic Drainage Mapping in Oropharyngeal Cancers
A study testing SPECT-CT in people with Oropharynx Cancer, run by University Health Network, Toronto at 4 sites in Canada.
Trial summary
The purpose of the study is to see how practical it is to inject a radiotracer called 99m-Technetium Sulfur Colloid around the tumors for the imaging of patients with oropharyngeal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oropharynx Cancer
- What is being tested?
- SPECT-CT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 4 sitesCanada
- Study dates
- 13 Sep 2021to 31 Oct 2023
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient has lateralized oropharyngeal carcinoma (tonsil or tongue base) not involving midline
- Has squamous cell carcinoma, T1-3 tumours, with no contralateral nodes on clinical exam or axial imaging
- Human papillomavirus (HPV) positive or negative
- Patient should have normal organ function as per Investigator judgement
- Patient is planned for definitive or adjuvant radiotherapy (RT) or chemo radiotherapy (CRT) with bilateral neck RT, or surgery
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Who cannot join
- T4 tumours
- Contralateral/bilateral nodal disease or node(s) > 6cm on clinical exam or axial imaging or positron emission tomography (PET)
- Primary tumour involving or crossing midline
- Soft palate or posterior pharyngeal wall tumour subsites
- Previous head and neck cancer
- Previous radiotherapy (RT) to the head and neck
Show all 12Show fewer
- Previous neck dissection
- Distant metastases
- Prior invasive malignancy (except non-melanoma skin cancer) unless disease free for 3 years
- Prior radiotracer allergy
- Multiple primary head and neck cancers
- Pregnancy
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, L8N 4A6
London Health Sciences Centre
London, Ontario, N6A 5W9
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
About this study
Official title: A Feasibility Trial of Lymphatic Mapping With SPECT-CT for Evaluating Contralateral Disease in Lateralized Oropharynx Cancer Using 99m-Technetium Sulfur Colloid
The purpose of the study is to see how practical it is to inject a radiotracer called 99m-Technetium Sulfur Colloid around the tumors for the imaging of patients with oropharyngeal cancer.
Read the detailed description
This study will evaluate a technique called lymphatic drainage mapping. This is a technique where a radiotracer (a radioactive material that can be seen with a special computed tomography [CT] scanner to create 3D images) is injected into a vein around the tumour, either with local anesthesia or under general anesthesia. The radiotracer that will be used for the lymphatic drainage mapping is called 99m-Technetium Sulfur Colloid. Images will be taken of neck to detect the movement of the radiotracer. This will allow the doctors to see the drainage pattern of the lymph nodes in the neck.
The information from this study will be used to better understand the tendency for oropharyngeal cancers to spread to lymph nodes. In addition, the information from this clinical trial will be used in future clinical studies to help specialists identify strategies to help plan treatment based on this type of imaging study.
- Conditions
- Oropharynx Cancer
- Being tested
- SPECT-CT
- Keywords
- Lymphatic Drainage Mapping, 99m-Technetium Sulfur Colloid
- Medical subject headings
- Oropharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPECT-CTDiagnostic test
99m-Technetium Sulfur Colloid will be injected prior to the scan.
| Study group | Role | What they receive |
|---|---|---|
| Lymphatic drainage mapping in patients with oropharynx cancer | Experimental | Participants will be given 4 to 6 injections of the radiotracer 99m-Technetium Sulfur Colloid by a needle into one of the veins of the radiotracer around the tumour.
Participants will then have at least 1 or possibly 2 SPECT-CT scans (a special x-ray scan of the body from many angles that are turned into 3-dimensional pictures on a screen). Receives: Diagnostic Test: SPECT-CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients injected with radiotracer.
Measured: 1 year
Proportion of patients requiring general anesthetic over local anesthetic.
Measured: 1 year
Proportion of patients with images that failed radiotracer migration to either side of the neck.
Measured: 1 year
Proportion of patients completing 30 minute scan.
Measured: 1 year
Proportion of patients completing 3 hour scan.
Measured: 1 year
Proportion of patients with radiotracer uptake into a radiographically positive lymph node.
Measured: 1 year
Proportion of patients with injections site locations that are compliant with protocol specific map of injection locations.
Measured: 1 year
Average time from start to finish of injection of procedure.
Measured: 1 year
Proportion of patients with complications associated with injection.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2021
- Study start13 Sep 2021
- Primary completion23 Oct 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oropharynx CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John de Almeida, M.D., Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05055206
- Sponsor's protocol ID
- SPECT-CT
- Other IDs
- 20-5607
- Status last verified
- Nov 2025
- First submitted
- 14 Sep 2021
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Trial of Lymphatic Mapping With SPECT-CT for Evaluating Contralateral Disease in Lateralized Oropharynx Cancer Using 99m-Technetium Sulfur Colloid
- ClinicalTrials.gov ID
- NCT05055206
- Acronym / sponsor ID
- SPECT-CT
- Conditions
- Oropharynx Cancer
- Keywords
- Lymphatic Drainage Mapping, 99m-Technetium Sulfur Colloid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 13 Sep 2021 (actual)
- Primary completion
- 23 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 24 Sep 2021 (actual)
- 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 the study is to see how practical it is to inject a radiotracer called 99m-Technetium Sulfur Colloid around the tumors for the imaging of patients with oropharyngeal cancer.
Detailed description
This study will evaluate a technique called lymphatic drainage mapping. This is a technique where a radiotracer (a radioactive material that can be seen with a special computed tomography [CT] scanner to create 3D images) is injected into a vein around the tumour, either with local anesthesia or under general anesthesia. The radiotracer that will be used for the lymphatic drainage mapping is called 99m-Technetium Sulfur Colloid. Images will be taken of neck to detect the movement of the radiotracer. This will allow the doctors to see the drainage pattern of the lymph nodes in the neck.
The information from this study will be used to better understand the tendency for oropharyngeal cancers to spread to lymph nodes. In addition, the information from this clinical trial will be used in future clinical studies to help specialists identify strategies to help plan treatment based on this type of imaging study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lymphatic drainage mapping in patients with oropharynx cancer | Experimental | Diagnostic Test: SPECT-CTParticipants will be given 4 to 6 injections of the radiotracer 99m-Technetium Sulfur Colloid by a needle into one of the veins of the radiotracer around the tumour. Participants will then have at least 1 or possibly 2 SPECT-CT scans (a special x-ray scan of the body from many angles that are turned into 3-dimensional pictures on a screen). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient has lateralized oropharyngeal carcinoma (tonsil or tongue base) not involving midline
- Has squamous cell carcinoma, T1-3 tumours, with no contralateral nodes on clinical exam or axial imaging
- Human papillomavirus (HPV) positive or negative
- Patient should have normal organ function as per Investigator judgement
- Patient is planned for definitive or adjuvant radiotherapy (RT) or chemo radiotherapy (CRT) with bilateral neck RT, or surgery
Key exclusion criteria (12 listed)
- T4 tumours
- Contralateral/bilateral nodal disease or node(s) > 6cm on clinical exam or axial imaging or positron emission tomography (PET)
- Primary tumour involving or crossing midline
- Soft palate or posterior pharyngeal wall tumour subsites
- Previous head and neck cancer
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-CT99m-Technetium Sulfur Colloid will be injected prior to the scan. | Diagnostic test | Lymphatic drainage mapping in patients with oropharynx cancer |
Primary outcome
Proportion of patients injected with radiotracer.
Time frame: 1 year
Proportion of patients requiring general anesthetic over local anesthetic.
Time frame: 1 year
Proportion of patients with images that failed radiotracer migration to either side of the neck.
Time frame: 1 year
Proportion of patients completing 30 minute scan.
Time frame: 1 year
Proportion of patients completing 3 hour scan.
Time frame: 1 year
Proportion of patients with radiotracer uptake into a radiographically positive lymph node.
Time frame: 1 year
Proportion of patients with injections site locations that are compliant with protocol specific map of injection locations.
Time frame: 1 year
Average time from start to finish of injection of procedure.
Time frame: 1 year
Proportion of patients with complications associated with injection.
Time frame: 1 year
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 Dec 2025.
- 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.
John de Almeida, M.D. principal investigator
University Health Network, Toronto
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SPECT-CT in people with Oropharynx Cancer, run by University Health Network, Toronto at 4 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 6 inclusion and 12 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 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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.
What does the primary outcome measure?
Proportion of patients injected with radiotracer. (time frame: 1 year). The study lists 9 primary outcomes in all. 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 3 Dec 2025.