Breast CancerPhase 1NCT01159405
The Study of Biodistribution and Dosimetry of 99mTc-Glycopeptide(99mTc-GP) in Patients With Breast Cancer
A Phase 1 study testing Radiolabeled (99mTc) GP (Glycopeptide) in people with Breast Cancer, run by SeeCure LLC at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the biodistribution and dosimetry of single dose of 99mTc-glycopeptide (99mTc-GP, 20-25 mCi) in 3 different doses of GP (5, 10and 20 mg)in patients with breast cancer at pre-chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Radiolabeled (99mTc) GP (Glycopeptide)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Apr 2015
- Phase
- 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
- Patients with newly diagnosed stage I-IV breast cancer (tumor size
- 2cm in imaging examinations) who are scheduled to start systemic therapy.
- Patients must have histological diagnosis of invasive breast cancer.
- Extent of disease will be determined by physical examination and conventional radiological studies.
- Must be age 18 or older.
- ECOG performance status 0-2.
Show all 10Show fewer
- Patients with history of prior malignancies must be disease-free for at least 5 years of study entry.
- Normal hematological function: WBC > 3000/ul, absolute neutrophil count > 1500/ul, platelets > 100,000/ul, and Hgb > 10 gms (transfusion to achieve Hgb > 10 gms is acceptable).
- Serum total bilirubin < 1.5 mg/dl and SGPT < 1.5 X normal.
- Adequate kidney function (creatinine < 1.5 mg/dL).
Who cannot join
- Patients who received previous chemotherapy for the newly diagnosed breast cancer.
- No evidence of primary breast lesion (e.g. T0, Tx).
- Pregnant women or sexually active women of childbearing potential who are not practicing adequate contraception are excluded.
- Patients with myocardial infarction within 6 months of study entry; unstable angina pectoris; uncontrolled congestive heart failure; uncontrolled arrhythmia are excluded.
- Patients with history of hypersensitivity/allergy to Chitosan/Chitin related shellfish foods.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Houston Methodist Hospital
Houston, Texas, 77030
Eileen Dickman, PhD, MBA, CCRC, 713-441-9777, edickman@houstonmethodist.org
Andrea Dotting, M.D, 713-441-8029, andotting@houstonmethodist.org
About this study
Official title: A Pilot Study of Biodistribution and Dosimetry of 99mTc-Glycopeptide (99mTc-GP) in Patients With Breast Cancer
The purpose of this study is to evaluate the biodistribution and dosimetry of single dose of 99mTc-glycopeptide (99mTc-GP, 20-25 mCi) in 3 different doses of GP (5, 10and 20 mg)in patients with breast cancer at pre-chemotherapy.
Read the detailed description
Cohorts of 3 will be treated each at different dose levels and images will be taken at 4 time points. For dosimetry estimates, there will be a 20-24 hr time point post-administration of 99mTc-GP for the first 3 patients. If the biodistribution and dosimetry can be adequately quantified without the 20-24 hr scan in 3 patients, then we will eliminate that 4th scan for all other patients. Urine and blood samples will be collected at 5 time points, and an additional blood and urine sample will be collected for dosimetry analysis at 30~60 min.
- Conditions
- Breast Cancer
- Being tested
- Radiolabeled (99mTc) GP (Glycopeptide)
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiolabeled (99mTc) GP (Glycopeptide)Radiation
one injection of Technetium Glycopeptide to yield a target activity of 20-25 mCi to be given by slow IV push (over 3-5 minutes) 5 mg, 10 mg \& 20 mg of GP will be injected
| Study group | Role | What they receive |
|---|---|---|
| 99mTc-GP | Experimental | 99mTc-GP with SPECT/CT imaging \& whole body scan. Receives: Radiation: Radiolabeled (99mTc) GP (Glycopeptide) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the best dose of 99mTc-GP in imaging based upon safety data and tumor-to background (T/B) count density ratios.
Measured: from 99mTc-GP injection through 30 days
Secondary outcomes (1)
To determine the optimal time to imaging after injection of 99mTc-GP based upon tumor to-background (T/B) count density ratios at various times.
Measured: from 99mTc-GP injection through 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2010 (estimated)
- Study startJun 2010
- Primary completionMar 2015 (estimated)
- Study completionApr 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast 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 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SeeCure LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tejal Patel, M.D., Principal investigator, Breast Medical Oncologist, Methodist Cancer Center, Houston, Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01159405
- Sponsor's protocol ID
- SeeCure GP-001
- Status last verified
- Jul 2014
- First submitted
- 8 Jul 2010
- Last updated
- 30 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Biodistribution and Dosimetry of 99mTc-Glycopeptide (99mTc-GP) in Patients With Breast Cancer
- ClinicalTrials.gov ID
- NCT01159405
- Acronym / sponsor ID
- SeeCure GP-001
- Conditions
- Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- SeeCure LLCIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Mar 2015 (estimated)
- Study completion
- Apr 2015 (estimated)
- First posted
- 9 Jul 2010 (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 evaluate the biodistribution and dosimetry of single dose of 99mTc-glycopeptide (99mTc-GP, 20-25 mCi) in 3 different doses of GP (5, 10and 20 mg)in patients with breast cancer at pre-chemotherapy.
Detailed description
Cohorts of 3 will be treated each at different dose levels and images will be taken at 4 time points. For dosimetry estimates, there will be a 20-24 hr time point post-administration of 99mTc-GP for the first 3 patients. If the biodistribution and dosimetry can be adequately quantified without the 20-24 hr scan in 3 patients, then we will eliminate that 4th scan for all other patients. Urine and blood samples will be collected at 5 time points, and an additional blood and urine sample will be collected for dosimetry analysis at 30~60 min.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 99mTc-GP | Experimental | Radiation: Radiolabeled (99mTc) GP (Glycopeptide)99mTc-GP with SPECT/CT imaging \& whole body scan. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients with newly diagnosed stage I-IV breast cancer (tumor size
- Patients must have histological diagnosis of invasive breast cancer.
- Extent of disease will be determined by physical examination and conventional radiological studies.
- Must be age 18 or older.
- ECOG performance status 0-2.
Key exclusion criteria (5 listed)
- Patients who received previous chemotherapy for the newly diagnosed breast cancer.
- No evidence of primary breast lesion (e.g. T0, Tx).
- Pregnant women or sexually active women of childbearing potential who are not practicing adequate contraception are excluded.
- Patients with myocardial infarction within 6 months of study entry; unstable angina pectoris; uncontrolled congestive heart failure; uncontrolled arrhythmia are excluded.
- Patients with history of hypersensitivity/allergy to Chitosan/Chitin related shellfish foods.
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 |
|---|---|---|
| Radiolabeled (99mTc) GP (Glycopeptide)one injection of Technetium Glycopeptide to yield a target activity of 20-25 mCi to be given by slow IV push (over 3-5 minutes) 5 mg, 10 mg \& 20 mg of GP will be injected | Radiation | 99mTc-GP |
Primary outcome
To determine the best dose of 99mTc-GP in imaging based upon safety data and tumor-to background (T/B) count density ratios.
Time frame: from 99mTc-GP injection through 30 days
1 secondary outcome
To determine the optimal time to imaging after injection of 99mTc-GP based upon tumor to-background (T/B) count density ratios at various times.
Time frame: from 99mTc-GP injection through 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2014.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Tejal Patel, M.D. principal investigator
Breast Medical Oncologist, Methodist Cancer Center, Houston, Texas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Radiolabeled (99mTc) GP (Glycopeptide) in people with Breast Cancer, run by SeeCure LLC 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 10 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: status not confirmed, as of the sponsor's last update on 30 Jul 2014. 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ning Tsao, PhD (7135719410, ning.tsao@seecurellc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the best dose of 99mTc-GP in imaging based upon safety data and tumor-to background (T/B) count density ratios. (time frame: from 99mTc-GP injection through 30 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 30 Jul 2014.