Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

intradermal injection of 2.5 milligrams of indocyanine green and 20 MBq of technetium 99 before breast surgery

intradermal injection of 20 MBq of technetium 99 before breast surgery

One injection, 2.5 milligrams per patient, intradermal use

indocyanine green

One injection, 20 MBq techntium99, intradermal use

isotope

Céline CHAULEUR, PhD

The sentinel node has a fundamental role in the management of early breast cancer.

Currently, the double detection of blue and radioisotope is recommended. A radioactive material requires the presence of a nuclear medicine department and the approval of health authorities. In many centers, this technique is not available. The use of blue is easier to implement technique. However, allergic reactions and prolonged breast tattoo led many teams to stop the practice.

So in common practice, many center use a single method. However, with a single detection, the risk of false negatives and the identification failure rate increased to a significant extent and the number of sentinel lymph node detected and removed is not enough.

Under these conditions, find another method of detection seems crucial. According to the literature, the fluorescence method (ICG) is a technique that seems safe and reliable.

The investigators therefore propose a prospective, randomized study to investigate the interest of fluorescence associated with the isotopic method.

Study Assessing The Interest of Indocyanine Green Fluorescence Imaging With Radioisotope Method For Sentinel Lymph Node Biopsy in Patients With Breast Cancer

Comparative, Prospective, Randomized Study Assessing The Interest of Indocyanine Green Fluorescence Imaging With Radioisotope Method For Sentinel Lymph Node Biopsy in Patients With Breast Cancer

Number of patients with less than two lymph nodes detected by indocyanine (ICG) + isotope versus isotope detection alone

Number of lymph nodes Indocyanine green (ICG) positive and Tc (Technetium)positive

Number of lymph nodes Indocyanine green (ICG) positive and Tc (Technetium) negative

Number of lymph nodes Indocyanine green (ICG) negative and Tc (Technetium) positive

time from the injection of anesthesic to the waking

time from injection of one dose ICG injection to incision time

time from incision time to the last node surgery

allergy is : redness, edema, itching, larynges edema and/or allergic shock

Centre Hospitalier Universitaire de Saint Etienne

intradermal injection of 2.5 milligrams of indocyanine green and 20 MBq of technetium 99 before breast surgery

indocyanine green: One injection, 2.5 milligrams per patient, intradermal use

isotope: One injection, 20 MBq techntium99, intradermal use

Double Detection Indocyanine + Isotope

intradermal injection of 20 MBq of technetium 99 before breast surgery

isotope: One injection, 20 MBq techntium99, intradermal use

Isotope Detection Alone

Total

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

height, continuous

weight, continuous

age of first menstruation, continuous

menopause

tumor size

Pr Céline CHAULEUR

Number of Patients With Less Than Two Lymph Nodes Detected

Number of Lymph Nodes ICG Positive and Tc Positive

Number of Lymph Nodes ICG Positive and Tc Negative

Number of Lymph Nodes ICG Negative and Tc Positive

Comparison Between Groups of the Time of the Surgery

Comparison Between Groups of Anesthesia Time

Time From Injection of One Dose ICG Injection to Incision Time

Comparison Between Groups of Time Surgery Node

Number of Patients With ICG Allergy

Overall Study

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Symptoms and General Pathology

Prostatic Neoplasms

Recurrence

Disease Attributes

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

All Drugs and Chemicals

Anti-Infective Agents

Fluorides

Listerine

Sodium Fluoride

Radiopharmaceuticals

Protective Agents

Anti-Infective Agents, Local

Participants will receive radium-223 treatment every 4 weeks for up to 6 cycles. 18F-NaF PET scans will be used to assess response in bone.

an alpha particle-emitting drug, dose consists of 55 kBq/kg (1.49 microcurie/kg); administered every 4 days

Radium-223

18F-NaF (Sodium Fluoride) is a radio-pharmaceutical used to image skeletal pathology with positron emission tomography (PET) imaging

18F Sodium Fluoride

Amy R Hankin, P.A.-C

Ravi A Madan, M.D.

For more information at the NIH Clinical Center contact National Cancer Institute Referral Office

Background:

Some men who have been treated for localized prostate cancer with surgery or radiation still show signs of the disease in their blood. This is called biochemically recurrent prostate cancer. Radium-223 is a small molecule. It uses radiation to kill cancer cells and improves survival in advanced prostate cancer. Researchers want to see if it can treat prostate cancer and induced immune changes earlier in the disease when the cancer is only detectable by prostate specific antigen (PSA) in the blood.

Objective:

To learn how Radium-223 affects men with rising PSA but no evidence of cancer on conventional CT or bone scan, but positive findings on PET or molecular imaging in the bones. The primary focus is impact on the immune system with secondary focus on impact on PSA and imaging.

Eligibility:

Men ages 18 and older with prostate cancer who have had surgery and/or radiation, but their PSA is rising even though no disease is visible on routine imaging scans (CT or bone scans). Patients are required to have PET or molecular imaging findings in bones, but not organs (lymph nodes are allowed).

Design:

Participants will be screened with a medical history and physical exam. Their ability to do normal tasks will be reviewed. They will give tissue samples or a report from their doctor about their cancer. They will have blood and urine tests. They will have an electrocardiogram to measure heart function. They will have a scan of their chest and abdomen using radiation or magnetic resonance imaging. They will have a bone scan with injection of Tc99. They will have a positron emission tomography scan with intravenous (IV) injection of 18F-NaF.

Participants will get Radium-223 by IV. For this, a small plastic tube is put into an arm vein. Radium-223 will be given on Day 1 of each cycle (1 cycle = 4 weeks) for up to 6 cycles. Participants will repeat the screening tests during the study. They will also complete Quality of Life Surveys and give stool samples.

After treatment, participants will have long-term follow-up every 6 weeks for the rest of their lives.

Background:

Androgen deprivation therapy (ADT) and surveillance are treatment options for prostate cancer patients with biochemical progression after localized therapy with either definitive radiation or surgery (biochemically recurrent prostate cancer). A primary goal in these patients is to prevent morbidity from their cancer that results from disease progression and metastatic disease on conventional imaging.

Radium-223 has demonstrated the ability to improve survival in men with symptomatic metastatic castration resistant prostate cancer (mCRPC) with a manageable toxicity profile, particularly in patients who have not yet received docetaxel.

Radiation, even at low doses can impact immune recognition and immune cell killing of cancer cells. Recent findings by the LTIB suggest that radium-223 potentiated T-cell killing of prostate cancer cells.

Radium-223 may present an alternative option for patients with BRPC that is not associated with substantial toxicity (as seen with ADT) and may have a lasting effect due to its potential effect on the immune system and/or the bone microenvironment.

Emerging PET imaging studies will likely find evidence of micrometastatic disease, often in the bones, in biochemically recurrent prostate cancer patients, although these patients will have no standard of care that can be supported by prospective data.

Radium-223 has demonstrated the ability to improve survival in men with symptomatic prostate cancer, but it remains unknown what the impact is in patients with micrometastatic or PET positive prostate cancer in their bones

Preclinical data has suggested that radium-223 can impact the immune system.

In addition, changes in PSA kinetics, changes on PET scan findings, and safety and tolerability of radium-223 in this population will also be evaluated.

Objective:

To determine statistically significant changes in immune cell populations compared to baseline in participants with biochemically recurrent or 18F NaF PET scan positive prostate cancer treated with radium-223

Eligibility:

Histologically confirmed adenocarcinoma of the prostate

Imaging showing positive findings on NaF PET, negative CT Scan and Tc-99m Bone Scan

Detectable PSA

ECOG 0-1

Design:

Single arm study

Participants will receive 6 injections of radium-223 with monthly assessments of PSA and periodic immune response. NaF PET scans will be completed at screening then at 4 and 7 months after the start of radium-223.

After completion of treatment participant will be followed every 6 (+/- 2 weeks).

Radium-223 in Biochemically Recurrent Prostate Cancer

Phase II Trial of Radium-223 in Biochemically Recurrent Prostate Cancer

.All IPD recorded in the medical record will be shared with intramural investigators upon request. In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP. All collected IPD will be shared with collaborators under the terms of collaborative agreements.

to determine the statistically significant changes in immune cell populations compared to baseline in participants with biochemically recurrent prostate cancer

rate of change in PSA per month compared against those on the surveillance arm of 16-C-0035

type, number and frequency of adverse events

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study Assessing The Interest of Indocyanine Green Fluorescence Imaging With Radioisotope Method For Sentinel Lymph Node Biopsy in Patients With Breast Cancer	NCT02279108	Breast Neoplasm...	indocyanine gre... isotope	18 Years -	Centre Hospitalier Universitaire de Saint Etienne
Radium-223 in Biochemically Recurrent Prostate Cancer	NCT04206319	Biochemical Rec...	Radium-223 18F Sodium Fluo...	18 Years -	National Institutes of Health Clinical Center (CC)

Spots Global Cancer Trial Database for isotope

Every month we try and update this database with for isotope cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for isotope

Every month we try and update this database with for isotope cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for isotope cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.