Back to results

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

Primary Purpose

Anal Cancer

Status

Withdrawn

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Lymphoseek

About this trial

This is an interventional diagnostic trial for Anal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lymphoseek - 0.5 mCi, 50 ug

Arm Description

A single dose of 50 µg Lymphoseek radiolabeled with 0.5 millicurie (mCi) (18.5 MBq) 99m Tc

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)

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)

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)

Incidence of Adverse Events

Full Information

NCT ID

NCT02857608

First Posted

August 2, 2016

Last Updated

March 13, 2017

Sponsor

Cardinal Health 414, LLC

1. Study Identification

Unique Protocol Identification Number

NCT02857608

Brief 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

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Withdrawn

Study Start Date

September 2016 (undefined)

Primary Completion Date

August 2017 (Anticipated)

Study Completion Date

August 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cardinal Health 414, LLC

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anal Cancer

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Lymphoseek - 0.5 mCi, 50 ug

Arm Type

Experimental

Arm Description

A single dose of 50 µg Lymphoseek radiolabeled with 0.5 millicurie (mCi) (18.5 MBq) 99m Tc

Intervention Type

Drug

Intervention Name(s)

Lymphoseek

Primary Outcome Measure Information:

Title

Time Frame

2-5 Days

Secondary Outcome Measure Information:

Title

Time Frame

2-5 Days

Title

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

Title

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

Title

Incidence of Adverse Events

Time Frame

5 Days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael Blue, MD

Organizational Affiliation

Cardinal Health 414, LLC

Official's Role

Study Director

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs