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Tests treatment safety and results for The Aim of the Study is to Evaluate the Efficacy of...
Official title Safety and Efficacy Study Using 5-ALA Oral Administration as an Adjuvant Therapy on the Rate of Local Tumor Recurrence in Patients Who Have Desmoids Tumors
ClinicalTrials.gov ID: NCT01898416
What this study is testing
What is 5-AMINOLEVULINIC ACID (5-ALA), is a non fluorescent prodrug.?
5-AMINOLEVULINIC ACID (5-ALA), is a non fluorescent prodrug. is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for the aim of the study is to evaluate the efficacy of photodynamic therapy as an.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to evaluate the efficacy of preoperative 5-ALA oral administration and subsequently intraoperative tumor bed phototherapy with red light laser, as an adjuvant therapy on the 3 years rate of local tumor recurrence in patients with desmoid tumors. To evaluate the Safety of 5-ALA administration.
- Phase 2: a mid-size study of how well it works
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
- Patient has a resectable histologically confirmed desmoid tumor.
- Previously treated (by chemotherapy, irradiation or surgery) patients are eligible.
- Age \> 18 years
- Signed informed consent prior to patient recruitment. -
You likely can't join if
- Hepatic enzymes or bilirubin \> 2X upper limit of normal.
- Serum creatinine \> 2.5 x upper limit of normal.
- Suspected /documented metastatic disease.
- Active or uncontrolled infections.
- Active second malignant disease (excluding non-melanoma skin cancer, or in situ cervix or breast carcinoma) \< 2 years prior to the study.
- Use of other investigational agents \< 30 days prior to the study.
See the full eligibility criteria
- Patient has a resectable histologically confirmed desmoid tumor.
- Previously treated (by chemotherapy, irradiation or surgery) patients are eligible.
- Age \> 18 years
- Signed informed consent prior to patient recruitment. -
- Hepatic enzymes or bilirubin \> 2X upper limit of normal.
- Serum creatinine \> 2.5 x upper limit of normal.
- Suspected /documented metastatic disease.
- Active or uncontrolled infections.
- Active second malignant disease (excluding non-melanoma skin cancer, or in situ cervix or breast carcinoma) \< 2 years prior to the study.
- Use of other investigational agents \< 30 days prior to the study.
- Patients who are mentally or physically unable to comply with all aspects of the study.
- Any serious medical condition, including the presence of laboratory abnormalities, which places the subject at an unacceptable risk if he or she participates in this study or confounds the experimental ability to...
- Pregnant or lactating females.
- Known intolerance or allergy to 5-ALA
- Suspicious or documented acute or chronic porphyria
The study team makes the final eligibility decision.
Where it's taking place
- Tel Aviv, Israel, Israel
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 Tel Aviv, Israel, Israel. 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.