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Samarium Sm-153 lexidronam

Analgesics, Non-Narcotic

Samarium 153-EDTMP tracer dose = 30 millicurie (mCi) by vein On Day 1. If enough study drug goes to bones, will receive a higher dose of 153 Sm-EDTMP, called a therapy dose, 7-14 days after the tracer dose. Stem Cell Transplant on Day 0, about 14-21 days after Samarium 153-EDTMP. Questionnaires taking about 15 minutes to complete.

Tracer dose = 30 mCi by vein On Day 1. If enough study drug goes to bones, will receive a higher dose of 153 Sm-EDTMP, called a therapy dose, 7-14 days after the tracer dose.

153 Sm-EDTMP

Questionnaires taking about 15 minutes to complete.

Questionnaire

Stem Cell Transplant on Day 0, about 14-21 days after Samarium 153-EDTMP.

Stem Cell Transplant

Naoto Ueno, MD, PhD

Primary objectives:

- To determine the time to progression in subjects with breast cancer metastatic to bone only treated with 153Sm-EDTMP and Autologous Peripheral Blood Stem Cell Transplantation (PBSCT).

Secondary objectives:

* To determine the overall survival at one year.
* To determine the efficacy of 153Sm-EDTMP at 6 months.
* To assess pain in subjects treated with 153Sm-EDTMP.
* To determine the safety of 153Sm-EDTMP.

153 Sm-EDTMP is designed to provide radiation to the bone and bone marrow. The radiation may kill cancer cells.

Before you can start treatment on this study, you will have "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. Your complete medical history will be recorded. You will have a physical exam. Blood (about 2 teaspoons) and urine will be collected for routine tests. You will have a breast exam, mammogram, and computed tomography (CT) scan. You will have a bone marrow aspirate/biopsy. To collect a bone marrow aspirate/biopsy, an area of the hip or chest bone is numbed with anesthetic, and a small amount of bone marrow/bone is withdrawn through a large needle. Blood (about 2 teaspoons) will be drawn to check the status of the disease. You will have x-rays, a bone scan, a positron emissions tomography (PET) scan, and a bone density test. Blood (about 2 teaspoons) will be drawn to check for HIV (the virus that causes AIDS), CMV (cytomegalovirus), Hepatitis B, and Hepatitis C (viruses that can infect the liver). You will have an electrocardiogram (ECG -- a test that measures the electrical activity of the heart). You will have an echocardiogram or multiple-gated acquisition scan (MUGA). An echocardiogram uses sound waves to make pictures of your heart, which helps show how well your heart pumps blood. You will be asked to lie on your left side while a technician places a probe with gel on your chest to create images of your heart to determine the function and size. You will have a lung function test to make sure your heart and lungs are healthy. You will complete a questionnaire about the pain you are experiencing. The questionnaire will take about 15 minutes to complete. Women who are able to have children must have a negative blood (about 2 teaspoons) pregnancy test.

If you are found to be eligible to take part in this study, on Day 1 you will receive a tracer dose. A tracer dose is a small amount of the study drug used to measure how the study drug is affecting the body. Your weight will be measured. Before the tracer dose is injected, you will be given fluids through a needle in your veins starting from 2 hours before the tracer dose up to 6 hours afterwards. You will receive a small amount of 153 Sm-EDTMP, called a tracer dose, through a needle in your vein.

After the tracer dose, you will have pictures taken of your body with a gamma camera 3 times that day. These photographs will be taken immediately after the dose is injected, and then 2-3 hours and 4-6 hours later. You will need to lie flat for these imaging sessions for about 10-30 minutes each time.

On Day 2, you will have 1 picture taken of your body with the gamma camera.

If, based on the photographs taken, doctors find that the drug does not go to your bones as expected, you will be removed from the study. If you leave the study at this point, you will have return to the clinic 2 times a week for the next 4 weeks. At these visits you will have a complete physical exam, and you will be asked about any side effects you may be experiencing.

If enough of the study drug does go to your bones, you will receive a higher dose of 153 Sm-EDTMP, called a therapy dose, 7-14 days after the tracer dose.

Before the therapy dose begins, you will have a physical exam, including measurement of your vital signs. Fluids will be given through a needle in your vein beginning 2 hours before the therapy dose and continuing up to 6 hours after.

You will receive the injection of 153 Sm-EDTMP through your central line. The injection will take about 15 minutes. Afterwards, your vital signs will be measured. Blood (about 2 teaspoons) will be drawn for routine tests.

The therapy dose of 153 Sm-EDTMP is expected to destroy your body's ability to make blood cells. To restore your blood-making ability, you will be given back stem cells (blood-forming cells) that will have already been taken from your body and stored for this treatment. This is called an autologous peripheral blood stem cell transplant. You will receive the stem cells given through a needle in your vein 14-21 days after the therapy dose usually as an outpatient procedure.

Family members may not be allowed with you until radiation subsides. This will reduce their exposure to radiation. You will be given instructions on how to follow radiation safety practices.

Once the radiation subsides you will be released from the hospital, at least 2 times a week you will have a complete physical exam, and you will be asked about any side effects you are experiencing. Blood (about 2 teaspoons) will be drawn up to 3 times a week until your stem cell transplant. Your vitals signs will also be checked 2 times a week.

After the transplant, at least 2 times a week for up to two (2) weeks your blood (about 2 teaspoons) will be drawn for routine tests. You will have a physical exam and your vital signs will be checked. You will receive additional care, drugs, or blood transfusions, as needed.

You will return for follow-up visits every 3 months until the end of Year 2 and then every 6 months in Years 3 and 4. Tests may occur more often if a side effect is noticed. Any side effects that you develop will be monitored until it goes away. Some of these exams and tests may take place with your home doctor, and these records will need to be sent to the study doctor so he/she can review them for careful monitoring.

In order to check the response of the cancer to the study therapy, you will have chest x-rays, CT scans, and bone scans every 3 months for the first 2 years after transplant. These will be repeated every 6 months in years 3-4 and once a year after that, as long as your cancer does not get worse. If the breast cancer has spread to your bone marrow at the time you enter this study, bone marrow biopsies will also be done at these times to see whether the cancer is responding. You will also have a PET scan at 6 months after transplant, and more often if your physician believes it will be helpful. Mammograms and bone density exams will be done once a year.

Once a year for the 10 years after you leave the study, you will have a study visit or you will be contacted by telephone. You will be asked about your general health, hospitalization, and cancer treatments.

This is an investigational study. 153 Sm-EDTMP is FDA-approved and commercially available for bone pain control. Up to 40 patients will take part in this study. All will be enrolled at M. D. Anderson.

Sm-EDTMP and Autologous Peripheral Blood Stem Cell Transplantation for Breast Cancer Patients With Bone Only Metastases

Phase 2 Study of 153 Sm-EDTMP Followed by Autologous Peripheral Blood Stem Cell Transplantation for Breast Cancer Patients With Bone Only Metastases

Time to progression is measured as the time from study entry to the development of disease progression.

Cytogen Corporation

M.D. Anderson Cancer Center

Samarium 153-EDTMP tracer dose = 30 millicurie (mCi) intravenous Day 1; or with study drug to bones, receive higher therapy dose of 153 Sm-EDTMP 7-14 days after tracer dose. Stem Cell Transplant Day 0, about 14-21 days after Samarium 153-EDTMP.

Samarium 153-EDTMP + Stem Cell Transplant

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Nato Ueno, MD, PhD/Professor, Breast Medical Oncology

Time to Progression

Overall Study

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Nervous System Diseases

Heart and Blood Diseases

Gland and Hormone Related Diseases

Behaviors and Mental Disorders

Respiratory Tract (Lung and Bronchial) Diseases

Musculoskeletal Diseases

Kidney Diseases

Parkinsonian Disorders

Heart Diseases

Thyroid Diseases

Dementia

Pulmonary Embolism

Embolism

Rheumatic Diseases

Collagen Diseases

Parathyroid Diseases

Urologic Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Brain Diseases

Central Nervous System Diseases

Thrombosis

Embolism and Thrombosis

Vascular Diseases

Lung Diseases

Respiratory Tract Diseases

Connective Tissue Diseases

Endocrine System Diseases

Ganglion Cysts

Synovial Cyst

Basal Ganglia Diseases

Movement Disorders

All patients will undergo scintigraphy on 2 distinct devices and the images obtained will be compared.

The scintigraphy of the patients will be carried out on 2 distinct devices and the images obtained will be compared.

Scintigraphy

Gilles METRARD, Dr

Monocentric study for the evaluation of a whole body CZT scintigraphy system.

Monocentric evaluation of performances and clinical interest of a whole body scintigraphic acquisition system with CZT digital detectors. Comparison of image quality and resolution of the new system compared to a reference one, on phantoms and during the acquisition of a wide variety of examinations.

Latest Imaging SPECT System Evaluation Phase 1

Rate of images obtaining a score greater than or equal to 4 in visual image quality analysis on a 5-point LIKERT scale.

Physical measurements of collimator performance on test object.

Centre Hospitalier Régional d'Orléans

Patients with a resection of the lesions according to the procedure SNOLL without the use of TReCam.

Patients with a resection of the lesions according to the procedure SNOLL with the use of TReCam.

TRECAM

Alexandre BRICOU, MD

In France, breast cancer affects approximately 53,000 new cases per year. The investigators have to take care more and more women with subclinical lesions (nonpalpable), and it represents around 25% to 35% of the diagnosed breast cancers. The main problem of the surgical management of these lesions is the quality of preoperative identification which determines the quality of surgery and oncological and cosmetic outcomes. For this type of lesion, SNOLL (Sentinel Node and Occult Lesion Localization) procedure could be proposed. This is a radioactive labeling of the tumor site and sentinel lymph node (SLN). The investigators want to evaluate the potential benefits of using a hand held camera called TreCam in this SNOLL procedure. This camera permits to obtain nuclear imaging at the bedside and in the operating theater.

Hypothesis:

The use of intraoperative TReCam improves the surgical procedure by providing relevant information during surgery to reduce the rate of further surgery for inappropriate margins.

Main Objective:

Evaluation of the contribution of TreCam in SNOLL procedure.

Main endpoint:

The rate of further surgery for inappropriate margins of the lumpectomy (less than 3mm)

Second endpoint:

Lumpectomy's characteristics, Cosmetics results Number of SLNs detected with TreCam at the different times of the procedure. Operative duration

Plan experimental :

Multicentric (3 centers) Phase II randomized non comparative study. All patients with non-palpable invasive cancer histologically proven and with ultrasound target will have SNOLL procedure.

Patients will be randomized preoperatively into two groups. Group 1: patients with a resection of the lesions according to the procedure SNOLL without the use of TReCam.

Group 2: patients with a resection of the lesions according to the procedure SNOLL with the use of TReCam.

In group 1:

* Day-1: Injection of Tc99m (Nanocis) in contact with the tumor under ultrasound guidance followed by a lymphoscintigraphy (LS): Localization and counting of the radioactive SLNs. Localization of the tumor site.
* Day 0: Before incision, exploration with the classic gamma probe (GP) for the localization of the different surgical areas (breast and axillary) is performed. Removal of SLN is achieved thanks to double detection (colorimetric and radioactive). After incision, radioactive SLN are identified by GP. At the end of the SLN procedure, the operator checks the absence of residual activity and controls with preoperative LS. In case of non detection of SLN or metastases identified during extemporaneous examination an axillary node dissection is performed. The GP is also used to guide lumpectomy and verify the absence of significant residual radioactivity after lumpectomy. Extemporaneous examination of lumpectomy specimen (size, limits of resection) is performed. Additional shaving of the cavity margins is appreciated by the surgeon.

In group 2 :

TReCam is used at different stages of SNOLL procedure:

* Day-1: A mapping with TReCam is performed after LS. (without LS results)
* Day 0: Before incision, in addition to GP, TReCam is used to define number and localization of SLN and the tumor site.

  * At the end of the usual SLN procedure, axillary area is also explored by TReCam in order to find residual SLN.
  * After lumpectomy, absence of significant residual radioactivity is checked by GP and TReCam
  * Operative duration will be reported.
  * Difficulties in data acquisition with TReCam.
  * Collection of all the histological results.
  * Outcome: Cosmetic results, decision of further surgery for inappropriate margins.

Total duration study: 13 months: Inclusion period : 12 months; Follow up : 1 month

Statistics

1. Sample size. This is a phase II 2-steps randomized non comparative study. N= 30 patients in each group. This will allow to test the potential interest of TReCAm in group 2 using an optimal II-stage design based on the number of patients without reintervention (success).

   The tested hypothesis are:

   H0: p=p0 avec p0 = 80% (poor technique) H1: p=p1\>p0 avec p1 = 95% (good technique) N= 30 patients per group will be considered, method proposed by R.P. A'Hern (Stat Med 2001 :20. 859-866).

   The required power was set at 80% and the alpha risk was set at 5%.
2. Strategy analysis of data collected

   Populations studied:

   The primary analysis will focus on all randomized patients (intention to treat analysis). Given the type of patients and the evaluation time of the primary endpoint, it is unlikely that there is lost sight. However, any patient with no information available on the primary endpoint will be classified as having a reoperation.
3. Justification of statistical tests

Descriptive analysis:

All quantitative parameters will be summarized descriptively in each group of treatment modality and for each time they are collected. The analysis will include descriptive statistics for each quantitative parameter each time: average, standard deviation, minimum, maximum, median and quartiles, number of missing values. Qualitative parameters are expressed by the frequency distribution and accurate bilateral confidence intervals to 95% associated. (asymptotic estimators will not be used because of the considered effective).

Hand-held Gamma Camera in the SNOLL Procedure

Contribution of a Hand-held Gamma Camera (TreCam) to the SNOLL(Occult Breast Lesion Localization Plus Sentinel Node Biopsy) Procedure in Breast Cancer

EXCELLENT: the treated breast is almost identical to untreated breast GOOD: minor difference between the treated breast and untreated breast. FAIR: obvious difference between the treated breast and untreated breast. POOR: major aesthetic and functional sequelae in the treated breast.

Volume of resection / tumor volume:

(Length x width x height) specimen / (π / 6) d3.(d is the histological maximum diameter of the lesion) Length x width x height) specimen / (π / 6) d3.(d is the histological maximum diameter of the lesion

The day before surgery, and at the day of surgery

Centre National de la Recherche Scientifique, France

Assistance Publique - Hôpitaux de Paris

nuclear breast imaging using MBI Gamma camera

nuclear breast imaging using MBI Gamma camera in addition to MRI

Gregory Pond

Karen Gulenchyn

To evaluate the feasibility, acceptability and safety of using a molecular breast imaging (MBI) Gamma Camera in women at high risk of developing breast cancer

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Sm-EDTMP and Autologous Peripheral Blood Stem Cell Transplantation for Breast Cancer Patients With Bone Only Metastases	NCT00429507	Breast Cancer Bone Metastases	153 Sm-EDTMP Questionnaire Stem Cell Trans...	18 Years - 65 Years	M.D. Anderson Cancer Center
Latest Imaging SPECT System Evaluation Phase 1	NCT04704349	Rheumatic Disea... Neoplasms Parathyroid Dis... Pulmonary Embol... Heart Diseases Thyroid Disease... Kidney Diseases Dementia Parkinsonian Di...	Scintigraphy	18 Years -	Centre Hospitalier Régional d'Orléans
Latest Imaging SPECT System Evaluation Phase 1	NCT04704349	Rheumatic Disea... Neoplasms Parathyroid Dis... Pulmonary Embol... Heart Diseases Thyroid Disease... Kidney Diseases Dementia Parkinsonian Di...	Scintigraphy	18 Years -	Centre Hospitalier Régional d'Orléans
Hand-held Gamma Camera in the SNOLL Procedure	NCT02101320	Breast Cancer	TRECAM	19 Years -	Assistance Publique - Hôpitaux de Paris
Study To Investigate the Feasibility and Safety of A Dedicated High Resolution Nuclear Breast Imaging Camera	NCT01062100	Breast Cancer	nuclear breast ...	18 Years -	Ontario Clinical Oncology Group (OCOG)

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