I125 TUMOR Localisation seeds
The I-125 Seed Source is a pre-sterilized 18G stainless steel needle containing low activity I-125 iodine seed. The I-125 source consists of a laser-welded titanium capsule containing iodine-125 adsorbed on a silver rod that acts as an x-ray detectable marker.
The aim of the I-125 Seed Source product is to more precisely locate a tumor in the breast tissue that cannot be palpated. I-125 Seed Source is used before surgery to assess the location of tumor tissue during surgery in female patients, over 18 years of age, that have been diagnosed with non-palpable tumor in breast tissue and who have been scheduled for a surgery to remove it. The I-125 Seed Source product is placed in the patient under mammography or ultrasound before surgery (surgical intervention). With the use of the product, the removal of the tumor in the breast tissue is performed with a higher sensitivity, while the damage to the healthy area is minimized.
Target patient population: Adult women (over 18 years of age) who have been diagnosed with breast cancer and are scheduled for surgery.
Physical properties…
Iodine-125 has a half-life of 59.4 days and decays due to the electron capture by the release of characteristic photons and electrons.
The major photon emissions are 27.2 keV, 27.5 keV, 31.0 keV and 35.5 keV with an average energy of 28.5 keV.
Table 1 indicates the decay chart of I-125 seeds.
Titanium tube properties: Grade 1 (It is not classified as implant class, as it will remain in the body for less than 29 days)
Tumor Marking Needle: 7 cm, 10 cm, 12 cm and 15 cm in length (should be selected according to breast type and size).
Needle Stopper: It is the barrier placed between the stylet and the tumor marking needle in order to prevent the I-125 seed source placed in the tumor marking needle from unintentionally leaving the tumor marking needle
Product Information Table
| CODE | CODE DESCRIPTION | INFO |
|---|---|---|
| I125S | Product Code (I-125 Seed Source) | In the product serial number, the "I125S" code is a fixed code describing the product |
| A | Needle Length (cm) | The "A" coding indicates the length of the tumour marking needle in the product component |
| B | Activity (MBq) | The "B" coding indicates the activity of the product |
| C | Production Year (Last Two Digits) | The "C" coding refers to the last two digits of the year in which the serial numbered product was produced. |
| D | Product Number | The "D" coding is the sequence number that identifies the product produced in the product serial number |
Product List
| Model No | Description | Activity | Sterility |
|---|---|---|---|
| I125S-7-2 | I-125 Loose Source(Single) in 18 Gauge x 7 cm Needle | 2 MBq | Sterile |
| I125S-7-9 | I-125 Loose Source(Single) in 18 Gauge x 7 cm Needle | 9 MBq | Sterile |
| I125S-10-2 | I-125 Loose Source(Single) in 18 Gauge x 10 cm Needle | 2 MBq | Sterile |
| I125S-10-9 | I-125 Loose Source(Single) in 18 Gauge x 10 cm Needle | 9 MBq | Sterile |
| I125S-12-2 | I-125 Loose Source(Single) in 18 Gauge x 12 cm Needle | 2 MBq | Sterile |
| I125S-12-9 | I-125 Loose Source(Single) in 18 Gauge x 12 cm Needle | 9 MBq | Sterile |
| I125S-15-2 | I-125 Loose Source(Single) in 18 Gauge x 15 cm Needle | 2 MBq | Sterile |
| I125S-15-9 | I-125 Loose Source(Single) in 18 Gauge x 15 cm Needle | 9 MBq | Sterile |
Information
STERLISATION - The I-125 seed source is sterilized with ethylene oxide. The sterile kit has a 180-day shelf life. If the product has expired, it is no longer sterile, and should thus not be used. Do not re-sterilize the product.
LOCALISATION, DOSAGE AND USAGE - The source activity level used for localization is 2 MBq and 9 MBq (54-243 Ci).
CALIBRATION - I-125 sources are measured on instruments calibrated with National Institute of Standards and Technology (NIST) standard sources.
STORAGE CONDITIONS - Temperature: 5C to 30C, relative humidity: 30%RH to 70%RH, absolute pressure: 100.0 kPa (14.504 psi, 0.987 atm)
INSTRUCTIONS FOR SAFE USE - Under guidance of standard ultrasonography or radiography, the radioactive seed enters with an 18G needle. The seed source is impelled to the style when the desired area of the lesion is reached. Each seed should be at least> 2 cm apart if multiple seeds are used in multiple lesions. By ultrasound or radiography, proper seed placement is confirmed. The seed should be taken during the process of excision.
PRECAUTIONS - The product should be stored in lead shield until it is ready to use. Use the lead protector and its content carefully to avoid damage to the product.
RADIATION PROTECTION AND TRANSPORT - The 27-35.5 keV photons of I-125 are largely absorbed by any high-Z material, but show the desired penetration into the tissue.
Half Value Thickness-Lead: 0.025 mm
Half Value Thickness-Texture: 20 mm
With a thin lead film, the dose rate can be decreased by 99.9%. (0.25 mm or 0.01 inch). Less dosage exposure to healthcare personnel and patients is ensured when used with I-125 preservatives. I-125 seed sources can be used only by individuals trained in the safe use and handling of radioisotopes by a competent government authority.
Direct contact with I-125 seed sources should be prevented. The use of tweezers is recommended. While operating with sources, appropriate measures should be taken. Personnel monitoring is needed. For the monitoring of hand and whole body exposure, dose measuring instruments such as personal dosimeters should be used. All practical measures should be taken during the preparation stage and during the implantation of the source to ensure that exposure is kept relatively low. Measures such as reducing exposure time, increasing distances, proper preparation of administrative procedures and the use of preservatives should be considered in order to maintain the target time.
LEAK TEST - Before delivery, I-125 Seed Sources were 100 percent leak tested. I-125 surface contamination passed leakage tests at a value below 0.2kBq in compliance with ‘ISO 9978 Radiation Safety – Sealed Radioactive Sources’ (5nCi). I-125 Seed Sources do not need to undergo any further leak testing if the expiry date has not expired.
