Uterine Cervical Neoplasms
Conditions
Brief summary
Prospective, open-label, within-patient, multi-center study of Lymphoseek in the detection of lymph nodes in subjects with known cancer of the cervix. All subjects will receive a single dose of 50 µg Lymphoseek radiolabeled with 2 mCi (74 MBq) Tc 99m.
Interventions
A single dose of 2 mCi (74 MBq) and 50 ug of Tc99m tilmanocept administered peritumorally no more than 20 hours before surgery
Sponsors
Cardinal Health 414, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject has provided written informed consent with HIPAA authorization * Has cervical cancer and is a candidate for surgical intervention, with lymph node dissection being a part of the surgical plan. * Is at least 18 years of age at the time of consent * Has an ECOG performance status of Grade 0 to 2 * Has the following International Federation of Gynecology and Obstetrics (FIGO) IA2-IIA1staging. Subjects with a single enlarged/suspicious node on PET/CT will still be considered eligible as consistent with FIGO guidelines. * 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 preoperative chemotherapy, immunotherapy, or radiation therapy within the 30 days prior to Lymphoseek administration * Has had previous surgery or radiation to node basins that would be involved in the ILM 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 * Is scheduled for surgery and/or another invasive procedure other than the primary surgical intervention within the 3 days after Lymphoseek administration * Has received an investigational product within the 30 days prior to Lymphoseek administration
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Per-subject False Negative Rate | 1 day | Proportion of subjects with pathologically negative Lymphoseek-identified SLNs and at least one pathologically positive non-SLN |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Per-subject Negative Predictive Value | 1 day | Proportion of subjects with pathologically negative Lymphoseek-identified SLN(s) with no pathologically positive lymph nodes |
| Per-subject Accuracy | 1 day | Proportion of subjects accurately indentified by Lymphoseek |
| Proportion of Lymph Nodes Identified Intraoperatively by a Dye That Are Also Identified by Lymphoseek | 1 day | — |
| Number of Lymph Nodes Per-subject Identified by Lymphoseek | 1 day | — |
| Per-subject Sensitivity | 1 day | Proportion of subjects with at least one pathologically positive Lymphoseek-identified SLN that have at least one pathologically positive lymph node |
| Per-subject Concordance | 1 day | Subjects whose lymph nodes were determined to be dye positive that were also identified by Lymphoseek |
| Per-subject Reverse Concordance | 1 day | Number of subjects whose lymph nodes that were identified by Lymphoseek were also all identified by dye |
| Incidence of Adverse Events | 7 days | — |
| Number of Lymph Nodes Per-subject Identified by Other Dyes | 1 day | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tc99m Tilmanocept Enrolled subjects who were administered any injection of Tc99m tilmanocept. | 18 |
| Total | 18 |
Baseline characteristics
| Characteristic | Tc99m Tilmanocept |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants |
| Age, Continuous | 38.53 years STANDARD_DEVIATION 7.56 |
| ECOG Status 0 | 18 Participants |
| ECOG Status 1 | 0 Participants |
| ECOG Status 2 | 0 Participants |
| ECOG Status 3 | 0 Participants |
| ECOG Status 4 | 0 Participants |
| ECOG Status 5 | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 14 Participants |
| Region of Enrollment United States | 18 participants |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 18 |
| other Total, other adverse events | 5 / 18 |
| serious Total, serious adverse events | 0 / 18 |
Outcome results
Primary
Per-subject False Negative Rate
Proportion of subjects with pathologically negative Lymphoseek-identified SLNs and at least one pathologically positive non-SLN
Time frame: 1 day
Population: Participants receiving a single dose of 50 µg Lymphoseek radiolabeled with 2 mCi (74 MBq) Tc 99m for whom at least one lymph node was removed with histopathology available
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intent-To-Treat | Per-subject False Negative Rate | .333 Proportion of Participants |
Secondary
Incidence of Adverse Events
Time frame: 7 days
Population: Enrolled subjects who were administered any injection of Tc99m tilmanocept.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intent-To-Treat | Incidence of Adverse Events | 5 Events |
Secondary
Number of Lymph Nodes Per-subject Identified by Lymphoseek
Time frame: 1 day
Population: Participants receiving a single dose of 50 µg Lymphoseek radiolabeled with 2 mCi (74 MBq) Tc 99m for whom at least one lymph node was removed with histopathology available
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intent-To-Treat | Number of Lymph Nodes Per-subject Identified by Lymphoseek | 2.72 Nodes Per Subject |
Secondary
Number of Lymph Nodes Per-subject Identified by Other Dyes
Time frame: 1 day
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intent-To-Treat | Number of Lymph Nodes Per-subject Identified by Other Dyes | 2.41 Nodes Per Subject |
Secondary
Per-subject Accuracy
Proportion of subjects accurately indentified by Lymphoseek
Time frame: 1 day
Population: Participants receiving a single dose of 50 µg Lymphoseek radiolabeled with 2 mCi (74 MBq) Tc 99m for whom at least one lymph node was removed with histopathology available
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intent-To-Treat | Per-subject Accuracy | .9444 Proportion of participants |
Secondary
Per-subject Concordance
Subjects whose lymph nodes were determined to be dye positive that were also identified by Lymphoseek
Time frame: 1 day
Population: Participants receiving a single dose of 50 µg Lymphoseek radiolabeled with 2 mCi (74 MBq) Tc 99m for whom at least one lymph node was removed with histopathology available
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intent-To-Treat | Per-subject Concordance | 1.0 Proportion of Condordant Subjects |
Secondary
Per-subject Negative Predictive Value
Proportion of subjects with pathologically negative Lymphoseek-identified SLN(s) with no pathologically positive lymph nodes
Time frame: 1 day
Population: Participants receiving a single dose of 50 µg Lymphoseek radiolabeled with 2 mCi (74 MBq) Tc 99m for whom at least one lymph node was removed with histopathology available
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intent-To-Treat | Per-subject Negative Predictive Value | .9375 Proportion of participants |
Secondary
Per-subject Reverse Concordance
Number of subjects whose lymph nodes that were identified by Lymphoseek were also all identified by dye
Time frame: 1 day
Population: Participants receiving a single dose of 50 µg Lymphoseek radiolabeled with 2 mCi (74 MBq) Tc 99m for whom at least one lymph node was removed with histopathology available
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intent-To-Treat | Per-subject Reverse Concordance | .8333 Proportion of Reverse Condordant Subj. |
Secondary
Per-subject Sensitivity
Proportion of subjects with at least one pathologically positive Lymphoseek-identified SLN that have at least one pathologically positive lymph node
Time frame: 1 day
Population: Participants receiving a single dose of 50 µg Lymphoseek radiolabeled with 2 mCi (74 MBq) Tc 99m for whom at least one lymph node was removed with histopathology available
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intent-To-Treat | Per-subject Sensitivity | .667 Proportion of participants |
Secondary
Proportion of Lymph Nodes Identified Intraoperatively by a Dye That Are Also Identified by Lymphoseek
Time frame: 1 day
Population: Participants receiving a single dose of 50 µg Lymphoseek radiolabeled with 2 mCi (74 MBq) Tc 99m for whom at least one lymph node was removed with histopathology available
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intent-To-Treat | Proportion of Lymph Nodes Identified Intraoperatively by a Dye That Are Also Identified by Lymphoseek | .8049 Proportion of Condordant Nodes |