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New treatment option for Soft Tissue Sarcoma
Official title HIFU Ablation of Soft Tissue Sarcoma
ClinicalTrials.gov ID: NCT05111964
What this study is testing
- What it's testing
- Around 3,300 people are diagnosed with soft tissue sarcoma (STS) each year in the UK, and a significant proportion of STS diagnoses are in people aged under 30 years. STS can arise from various tissue types and is comprised of over 50 tumour types.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- \-------- The participant is eligible for the study if they are: Willing and able to give informed consent for participation in the study. Aged 18...
- Malignant fibrous histiocytoma
- Undifferentiated (pleomorphic) sarcoma
- Fibrosarcoma and fibromyxoid sarcoma (fibroblastic sarcomas)
- Leiomyosarcoma
You likely can't join if
- \-------- The participant may not enter the study if ANY of the following apply: Diagnosed with histologically confirmed Osteosarcoma or Chordoma...
- GIST
- Chondrosarcoma
- Kaposi's sarcoma
- Ewings sarcoma
- Giant cell tumour
See the full eligibility criteria
- \-------- The participant is eligible for the study if they are: Willing and able to give informed consent for participation in the study. Aged 18 years or above. Diagnosed with histologically-confirmed and...
- Malignant fibrous histiocytoma
- Undifferentiated (pleomorphic) sarcoma
- Fibrosarcoma and fibromyxoid sarcoma (fibroblastic sarcomas)
- Leiomyosarcoma
- Liposarcoma
- Malignant peripheral nerve sheath tumour
- Retroperitoneal sarcoma
- Rhabdomyosarcoma
- Synovial sarcoma
- Sacral chordoma (following amendment)
- Desmoid tumours (intra- or extra-abdominal, following amendment) Have at least one of the following:
- Untreated or recurrent primary resectable STS tumour 1-5cm diameter, targetable by HIFU
- Infield recurrent primary resectable STS tumour of \>1cm diameter, targetable by HIFU
- Primary or metastatic STS unsuitable for resection or further chemo- or radiotherapy, targetable by HIFU
- Small (1-8cm) symptomatic intra- or extra-abdominal desmoid tumour, targetable by HIFU, which is not indicated for surgery (or patient has declined surgery) Have life expectancy of over 12 months and a World Health...
- \-------- The participant may not enter the study if ANY of the following apply: Diagnosed with histologically confirmed Osteosarcoma or Chordoma Diagnosed with histologically confirmed soft tissue sarcoma of the...
- GIST
- Chondrosarcoma
- Kaposi's sarcoma
- Ewings sarcoma
- Giant cell tumour
- Angiosarcoma Active medical or psychological illness that would render the patient unsuitable for the interventions required for the study (exclusion at the discretion of the investigator). Pregnancy. Ulceration / skin...
- Retroperitoneum
- Skull
- Neck
- Axilla
- Foot Unfavourable imaging features on previously acquired cross-sectional imaging, including:
- Tumour within 1cm of the skin surface
- Interposition (or close proximity) of a gas-containing structure between tumour and skin such as fixed (retroperitoneal) bowel or lung
- Interposition of a continuous ossified bone between tumour and skin, such as coverage by pelvis or scapula
- Tumour margin close (\<1.5cm) or encasing major neurovascular bundles (such as the sciatic nerve)
- Tumour margin close (\<1.5 cm) to critical visceral structures (e.g. bladder or bowel) Recent radiotherapy (under 6 months) to the target tumour site. Recent surgery (under 6 weeks) to the target tumour site. Have any...
The study team makes the final eligibility decision.
Where it's taking place
- Oxford, Oxfordshire, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Oxford, Oxfordshire, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.