Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06409013
Other study ID # 23-003589
Secondary ID NCI-2024-0348223
Status Recruiting
Phase
First received
Last updated
Start date March 14, 2024
Est. completion date March 30, 2027

Study information

Verified date May 2024
Source Mayo Clinic
Contact Clinical Trials Referral Office
Phone 855-776-0015
Email mayocliniccancerstudies@mayo.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study evaluates the effectiveness of intraoperative indocyanine green dye and fluoroscopic technology in confirming negative margins after tumor removal.


Description:

PRIMARY OBJECTIVE: I. To evaluate the use of indocyanine green (ICG) as an intraoperative guide during bone and soft tissue sarcoma resection. OUTLINE: This is an observational study. Patients receive ICG infusion prior to undergoing scheduled resection and have medical records reviewed on study.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date March 30, 2027
Est. primary completion date March 30, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients with biopsy-proven bone or soft tissue sarcoma undergoing resection Exclusion Criteria: - * Age less than 18 - Chronic kidney disease - Anaphylaxis to dyes

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Non-Interventional Study
Non-interventional study

Locations

Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Accuracy of intraoperative ICG fluorescence compared to final pathology results Intraoperative ICG fluorescence and deduced margins will be analyzed and compared the accuracy to final pathology margins. Negative predictive value will be calculated. Baseline
See also
  Status Clinical Trial Phase
Recruiting NCT02910895 - A Platform of Patient Derived Xenografts (PDX) and 2D/3D Cell Cultures of Soft Tissue Sarcomas (STS) N/A
Recruiting NCT05621668 - A First-In-Human Phase 1 Trial of T-Cell Membrane-Anchored Tumor Targeted Il12 (Attil12)- T-Cell Therapy in Subjects With Advanced/Metastatic Soft Tissue and Bone Sarcoma Phase 1
Active, not recruiting NCT04032964 - Dose Finding Study of L19TNF and Doxorubicin in Patients With STS Phase 1
Active, not recruiting NCT04577014 - Retifanlimab (Anti-PD-1 Antibody) With Gemcitabine and Docetaxel in Patients With Advanced Soft Tissue Sarcoma Phase 1/Phase 2
Completed NCT01650077 - Therapeutic Response of Patients With Soft Tissue Sarcoma According to CHOI Criteria
Withdrawn NCT04906876 - A Phase 2 Study of 9-ING-41Combined With Chemotherapy in Adolescents and Adults With Advanced Sarcomas Phase 2
Terminated NCT02890368 - Trial of Intratumoral Injections of TTI-621 in Subjects With Relapsed and Refractory Solid Tumors and Mycosis Fungoides Phase 1
Terminated NCT02628535 - Safety Study of MGD009 in B7-H3-expressing Tumors Phase 1
Completed NCT02204111 - Patient Directed Intervention to Improve the Quality of Life for Patients With Soft Tissue Sarcoma
Withdrawn NCT01663090 - Ferumoxytol-Enhanced MRI in Adult/Pedi Sarcomas N/A
Completed NCT01259375 - Amrubicin Chemotherapy as First Line in Metastatic or Unresectable Soft Tissue Sarcoma Phase 2
Completed NCT01440088 - A Trial of TH-302 in Combination With Doxorubicin Versus Doxorubicin Alone to Treat Patients With Locally Advanced Unresectable or Metastatic Soft Tissue Sarcoma Phase 3
Completed NCT01106872 - Bevacizumab, Chemotherapy and Valproic Acid in Advanced Sarcomas Phase 1
Recruiting NCT00753727 - Sunitinib and Radiation in Patients With Resectable Soft-tissue Sarcoma Phase 1/Phase 2
Terminated NCT00755261 - Phase II Study of Doxorubicin and Avastin® in Sarcoma. Phase 2
Completed NCT00611078 - Environmental Pollutants and the Risk of Soft Tissue Sarcoma: A Pilot Study N/A
Completed NCT00580320 - Safety Study of Dacarbazine and Bortezomib in Melanoma and Soft Tissue Sarcoma Phase 1
Completed NCT03452644 - US-Guided Biopsy in the Diagnosis of Musculoskeletal Soft-Tissue Tumors
Recruiting NCT05539677 - Biobank and Register of Patients With Agresive Tumors for Translational and Analytical Research
Terminated NCT03520959 - A Phase 3, Randomized, Double-blind, Placebo-controlled Study For Subjects With Locally-advanced Unresectable or Metastatic Synovial Sarcoma (V943-003, IMDZ-04-1702) Phase 3