Anal CancerPhase 2NCT02857608
A Prospective, Open-Label, Multi-center Comparison of Lymphoseek Identified Lymph Nodes and Clinically Identified Lymph Nodes of Subjects With Known Cancer of the Anus
A Phase 2 study testing Lymphoseek in people with Anal Cancer, run by Cardinal Health 414, LLC.
Trial summary
Prospective, open-label, within-subject, multi-center pilot study of Lymphoseek in the detection of lymph nodes in subjects with known squamous cell carcinoma of the anus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anal Cancer
- What is being tested?
- Lymphoseek
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Aug 2017
- Phase
- Phase 2
- 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
- Subject has provided written informed consent with Health Insurance Portability and Accountability Act of 1996 (HIPAA) authorization
- Has histologically confirmed squamous cell carcinoma of the anus (anal canal or perianus)
- Has a documented clinical stage using the tumor, lymph node, metastasis staging (TNM) classification system that was established by at least physical exam with manual palpation, digital anorectal examination, high-resolution anoscopy and PET/CT imaging evaluation of the bilateral inguinal area
- Is at least 18 years of age at the time of consent
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of Grade 0 to 3
- If of childbearing potential, the subject has a negative pregnancy test within 48 hours before administration of Lymphoseek, has been surgically sterilized, or has been postmenopausal for at least 1 year
Who cannot join
- The subject has had radiation therapy, chemotherapy or immunotherapy within the 30 days prior to Lymphoseek administration
- Has had previous surgery or node dissection (exclusive of fine needle aspiration) or radiation to node basins that would be involved in the intraoperative lymphatic mapping procedure
- Has a known allergy to dextran
- Is breast-feeding or pregnant
- Before the administration of Lymphoseek, has received any radiopharmaceutical within 7 radioactive half-lives of that radiopharmaceutical
- Has received an investigational product within the 30 days prior to Lymphoseek administration
About this study
Prospective, open-label, within-subject, multi-center pilot study of Lymphoseek in the detection of lymph nodes in subjects with known squamous cell carcinoma of the anus.
Read the detailed description
Prospective, open-label, within-subject, multi-center pilot study of Lymphoseek in the detection of lymph nodes in subjects with known squamous cell carcinoma of the anus. All subjects will receive a single dose of 50 µg Lymphoseek radiolabeled with 0.5 millicurie (mCi) (18.5 MBq) 99mTc.
- Conditions
- Anal Cancer
- Being tested
- Lymphoseek
- Medical subject headings
- Anus Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LymphoseekDrug
| Study group | Role | What they receive |
|---|---|---|
| Lymphoseek - 0.5 mCi, 50 ug | Experimental | A single dose of 50 µg Lymphoseek radiolabeled with 0.5 millicurie (mCi) (18.5 MBq) 99m Tc Receives: Drug: Lymphoseek |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance (the proportion of the number of subjects with lymph nodes identified by Lymphoseek and standard of care methods compared to the number of subjects with lymph nodes identified by standard of care methods)
Measured: 2-5 Days
Secondary outcomes (4)
Reverse Concordance (the proportion of the number of subjects with lymph nodes identified by Lymphoseek and standard of care methods compared to the number of subjects with lymph nodes identified by Lymphoseek)
Measured: 2-5 Days
Nodal Concordance (the proportion of the number lymph nodes identified by Lymphoseek and standard of care methods compared to the number of lymph nodes identified by standard of care methods)
Measured: 2-5 Days
Reverse Nodal Concordance (the proportion of the number lymph nodes identified by Lymphoseek and standard of care methods compared to the number of lymph nodes identified by Lymphoseek)
Measured: 2-5 Days
Incidence of Adverse Events
Measured: 5 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2016 (estimated)
- Study startSep 2016
- Primary completionAug 2017 (estimated)
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anal CancerStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardinal Health 414, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Blue, MD, Study director, Cardinal Health 414, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02857608
- Sponsor's protocol ID
- NAV3-20
- Status last verified
- Mar 2017
- First submitted
- 2 Aug 2016
- Last updated
- 15 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open-Label, Multi-center Comparison of Lymphoseek Identified Lymph Nodes and Clinically Identified Lymph Nodes of Subjects With Known Cancer of the Anus
- ClinicalTrials.gov ID
- NCT02857608
- Acronym / sponsor ID
- NAV3-20
- Conditions
- Anal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Cardinal Health 414, LLCIndustry (pharma, biotech, devices)
- Study start
- Sep 2016
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 5 Aug 2016 (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.
Prospective, open-label, within-subject, multi-center pilot study of Lymphoseek in the detection of lymph nodes in subjects with known squamous cell carcinoma of the anus.
Detailed description
Prospective, open-label, within-subject, multi-center pilot study of Lymphoseek in the detection of lymph nodes in subjects with known squamous cell carcinoma of the anus. All subjects will receive a single dose of 50 µg Lymphoseek radiolabeled with 0.5 millicurie (mCi) (18.5 MBq) 99mTc.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lymphoseek - 0.5 mCi, 50 ug | Experimental | Drug: LymphoseekA single dose of 50 µg Lymphoseek radiolabeled with 0.5 millicurie (mCi) (18.5 MBq) 99m Tc |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject has provided written informed consent with Health Insurance Portability and Accountability Act of 1996 (HIPAA) authorization
- Has histologically confirmed squamous cell carcinoma of the anus (anal canal or perianus)
- Has a documented clinical stage using the tumor, lymph node, metastasis staging (TNM) classification system that was established by at least physical exam with manual palpation, digital anorectal examination, high-resolution anoscopy and PET/CT imaging evaluation of the bilateral inguinal area
- Is at least 18 years of age at the time of consent
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of Grade 0 to 3
Key exclusion criteria (6 listed)
- The subject has had radiation therapy, chemotherapy or immunotherapy within the 30 days prior to Lymphoseek administration
- Has had previous surgery or node dissection (exclusive of fine needle aspiration) or radiation to node basins that would be involved in the intraoperative lymphatic mapping procedure
- Has a known allergy to dextran
- Is breast-feeding or pregnant
- Before the administration of Lymphoseek, has received any radiopharmaceutical within 7 radioactive half-lives of that radiopharmaceutical
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 |
|---|---|---|
| Lymphoseek | Drug | Lymphoseek - 0.5 mCi, 50 ug |
Primary outcome
Concordance (the proportion of the number of subjects with lymph nodes identified by Lymphoseek and standard of care methods compared to the number of subjects with lymph nodes identified by standard of care methods)
Time frame: 2-5 Days
4 secondary outcomes
Reverse Concordance (the proportion of the number of subjects with lymph nodes identified by Lymphoseek and standard of care methods compared to the number of subjects with lymph nodes identified by Lymphoseek)
Time frame: 2-5 Days
Nodal Concordance (the proportion of the number lymph nodes identified by Lymphoseek and standard of care methods compared to the number of lymph nodes identified by standard of care methods)
Time frame: 2-5 Days
Reverse Nodal Concordance (the proportion of the number lymph nodes identified by Lymphoseek and standard of care methods compared to the number of lymph nodes identified by Lymphoseek)
Time frame: 2-5 Days
Incidence of Adverse Events
Time frame: 5 Days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2017.
- Individual participant dataSharing planned: No
Related trials for Anal Cancer
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 2
Study of Pembrolizumab, Carboplatin, Paclitaxel, and Radiation for the Treatment of Early-Stage Anal Cancer
Anal Cancer
Active, not recruitingPhase 2
Anti-PD-1 and mDCF Followed by Chemoradiotherapy in Patients With Stage III Squamous Cell Anal Carcinoma.
Squamous Cell Carcinoma of the Anus Stage III
Recruiting
Distance-Based Exercise to Preserve Function and Prevent Disability
Localized Malignant Solid Neoplasm, Anal Cancer
Active, not recruitingPhase 2
Combination of Spartalizumab, mDCF and Radiotherapy in Patients With Metastatic Squamous Cell Anal Carcinoma
Squamous Cell Anal Carcinoma, Metastatic Squamous Cell Carcinoma
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.
Michael Blue, MD study director
Cardinal Health 414, LLC
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lymphoseek in people with Anal Cancer, run by Cardinal Health 414, LLC.
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 6 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: withdrawn, as of the sponsor's last update on 15 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was withdrawn before enrolling participants, so there are no results.
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?
Concordance (the proportion of the number of subjects with lymph nodes identified by Lymphoseek and standard of care methods compared to the number of subjects with lymph nodes identified by standard of care methods) (time frame: 2-5 Days). 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 15 Mar 2017.