Immunostimulating Interstitial Laser Thermotherapy in Breast Cancer

Watumiaji waliosajiliwa tu ndio wanaweza kutafsiri nakala

Ingia / Ingia

Kiungo kimehifadhiwa kwenye clipboard

HaliImekamilika

Wadhamini

Clinical Laserthermia Systems AB

Washirika

Nottingham University Hospitals NHS Trust

JARIBIO LA KLINIKI: NCT03039127

BioSeek: nct03039127

Maneno muhimu

Kikemikali

Thermotherapy is a technology aiming at destroying tissue, for example tumor tissue. Immunostimulating Interstitial Laser Thermotherapy (imILT) is a specific form of thermotherapy, which, in addition to destroying tumor tissue, has been optimized to cause a tumor specific immunologic response. In laboratory animals the imILT method has also been shown to induce a so called abscopal effect. This means that when one tumor is treated with imILT other, untreated, tumors also decrease in size. The immunologic response has previously been characterized in breast cancer patients after receiving imILT treatment , and presumed abscopal effects induced by imILT have also been described in a malignant melanoma patient.

The purpose of this trial is to investigate the functionality and safety of the imILT treatment method in patients diagnosed with breast cancer.

The treatment method has successfully been used for treatment of patients with breast cancer and malignant melanoma. Treatment of breast cancer patients caused an increase of cytotoxic T lymphocytes in the treated tumor, as well as activated dendritic cells at the tumor border. Regulatory T lymphocytes decreased in the regional lymph nodes.

This trial is explorative, prospective, open and non-randomized. Five breast cancer patients will be treated in this trial, which is estimated to be carried out during a time period of 9 months.

Tarehe

Imethibitishwa Mwisho:	12/31/2018
Iliyowasilishwa Kwanza:	06/28/2016
Uandikishaji uliokadiriwa Uliwasilishwa:	01/29/2017
Iliyotumwa Kwanza:	01/31/2017
Sasisho la Mwisho Liliwasilishwa:	01/28/2019
Sasisho la Mwisho Lilichapishwa:	01/29/2019
Tarehe halisi ya kuanza kwa masomo:	05/31/2016
Tarehe ya Kukamilisha Msingi iliyokadiriwa:	06/30/2018
Tarehe ya Kukamilisha Utafiti:	07/31/2018

Hali au ugonjwa

Breast Neoplasms

Uingiliaji / matibabu

Device: imILT

Awamu

Vikundi vya Arm

Mkono	Uingiliaji / matibabu
Experimental: imILT Immunostimulating Interstitial Laser Thermotherapy (imILT)	Device: imILT Immunostimulating Interstitial Laser Thermotherapy (imILT) is a specific form of thermotherapy, which, in addition to destroying tumor tissue, has been optimized to cause a tumor specific immunologic response.

Vigezo vya Kustahiki

Jinsia Inastahiki Kujifunza

All

Hupokea Wajitolea wa Afya

Ndio

Vigezo

Inclusion Criteria:

1. Have histologically confirmed breast cancer

2. Hormone receptor positive or negative

3. Have assessable tumour by MRI or ultrasound

4. Are patients deemed unfit for surgical excision of tumour under general anaesthetic.

5. Have been given informed verbal and written consent for participation in the trial

6. Have stable hematologic, renal and hepatic functions.

Exclusion Criteria:

1. Are known to be HIV positive

2. Have active autoimmune disease

3. Are on corticosteroid medication

4. Have evidence of bleeding diathesis or coagulopathy.

Matokeo

Hatua za Matokeo ya Msingi

1. Treatment effect by radiology [9 months]

Evaluation by Response Evaluation Criteria in Solid Tumours (RECIST)

Hatua za Matokeo ya Sekondari

1. Safety (adverse events) [9 months]

Evaluation of adverse events and laboratory analyses.

2. Usability (user evaluation of instrument) [9 months]

Analysis of instrument and user questionnaires relating to the ease of use.