Head and Neck CancerEarly Phase 1NCT01359267
Feasibility of Imaging in the Treatment of Patients With Advanced Head and Neck Cancer
A Early Phase 1 study testing 99mTc-EC-DG in people with Head and Neck Cancer, run by University of Chicago at 1 site in United States.
Trial summary
The purpose of this study is to obtain preliminary information on the potential of 99m Tc-EC-DG SPECT imaging to distinguish cancer from non cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- 99mTc-EC-DG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Apr 2011to 15 Sep 2015
- 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
- Treatment naive patients with histologically proven cancer of the head and neck
- T4 primary tumor (all sites), N2 or N3 locoregional disease (all sites)
- At least one measurable site of disease
- At least 18 years of age
- Karnofsky performance status > or = 70% or ECOG <2
- Able to tolerate SPECT/CT imaging
Show all 11Show fewer
- Adequate bone marrow function
- Adequate liver function
- Adequate renal function
- Written consent from patients
- Female patients of childbearing potential must have a negative pregnancy test within 0-7 days prior to the first SPECT study
Who cannot join
- Diabetics with insulin dependence or blood sugar levels >200 mg/dL prior to imaging
- Patient weight above the SPECT/CT table weight limit
- Pregnant and/or lactating female
- Unequivocal demonstration of metastatic disease
- Patients unwilling to or unable to comply with protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Feasibility Study of 99mTc EC DG SPECT/CT Imaging in the Treatment Response Evaluation in Patients With Locally Advanced Head and Neck Cancer
The purpose of this study is to obtain preliminary information on the potential of 99m Tc-EC-DG SPECT imaging to distinguish cancer from non cancer.
- Conditions
- Head and Neck Cancer
- Being tested
- 99mTc-EC-DG
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
99mTc-EC-DGDrug
99mTc-EC-DG will be used before the SPECT/CT scans throughout the study to determine the its effectiveness. 20 mCi of 99mtc-EC-DG will be administered through a vein through a catheter. This will be done before the SPECT/CT scan at 4 weeks and 10 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Imaging | Experimental | Not described Receives: Drug: 99mTc-EC-DG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Persistent Disease within 6 months of CRT
Measured: 6 months
Secondary outcomes (1)
Persistent Disease within 2 years of CRT
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2011 (estimated)
- Study start19 Apr 2011
- Primary completion15 Sep 2015
- Study completion15 Sep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Everett Vokes, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01359267
- Sponsor's protocol ID
- 11-0032
- Status last verified
- May 2020
- First submitted
- 20 May 2011
- Last updated
- 8 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Feasibility Study of 99mTc EC DG SPECT/CT Imaging in the Treatment Response Evaluation in Patients With Locally Advanced Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT01359267
- Acronym / sponsor ID
- 11-0032
- Conditions
- Head and Neck Cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 19 Apr 2011 (actual)
- Primary completion
- 15 Sep 2015 (actual)
- Study completion
- 15 Sep 2015 (actual)
- First posted
- 24 May 2011 (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 obtain preliminary information on the potential of 99m Tc-EC-DG SPECT imaging to distinguish cancer from non cancer.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Imaging | Experimental | Drug: 99mTc-EC-DG |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Treatment naive patients with histologically proven cancer of the head and neck
- T4 primary tumor (all sites), N2 or N3 locoregional disease (all sites)
- At least one measurable site of disease
- At least 18 years of age
- Karnofsky performance status > or = 70% or ECOG <2
Key exclusion criteria (5 listed)
- Diabetics with insulin dependence or blood sugar levels >200 mg/dL prior to imaging
- Patient weight above the SPECT/CT table weight limit
- Pregnant and/or lactating female
- Unequivocal demonstration of metastatic disease
- Patients unwilling to or unable to comply with protocol
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 |
|---|---|---|
| 99mTc-EC-DG99mTc-EC-DG will be used before the SPECT/CT scans throughout the study to determine the its effectiveness. 20 mCi of 99mtc-EC-DG will be administered through a vein through a catheter. This will be done before the SPECT/CT scan at 4 weeks and 10 weeks. | Drug | Imaging |
Primary outcome
Persistent Disease within 6 months of CRT
Time frame: 6 months
1 secondary outcome
Persistent Disease within 2 years of CRT
Time frame: 2 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 8 May 2020.
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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.
Everett Vokes, MD principal investigator
University of Chicago
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 99mTc-EC-DG in people with Head and Neck Cancer, run by University of Chicago 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 11 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 8 May 2020. 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?
Persistent Disease within 6 months of CRT (time frame: 6 months). 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 8 May 2020.