NCT01886235

Intravital Microscopy for Identifying Tumor Vessels in Patients With Stage IA-IV Melanoma That is Being Removed by Surgery

Completed NA Results posted Last updated 7 August 2020

What this trial tests

NA trial testing Diagnostic Microscopy in Recurrent Melanoma in 10 participants. Completed in 6 May 2020.

Timeline

4 September 2013

Primary endpoint
16 June 2015

6 May 2020

Quick facts

Lead sponsor	Roswell Park Cancer Institute
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	10
Start date	4 September 2013
Primary completion	16 June 2015
Estimated completion	6 May 2020
Sites	1 location across United States

Drugs / interventions tested

• Diagnostic Microscopy
• Fluorescein Sodium Injection
• Laboratory Biomarker Analysis — full drug profile →
• Therapeutic Conventional Surgery

Conditions studied

• Recurrent Melanoma — all drugs for Recurrent Melanoma →
• Stage IA Skin Melanoma — all drugs for Stage IA Skin Melanoma →
• Stage IB Skin Melanoma — all drugs for Stage IB Skin Melanoma →
• Stage IIA Skin Melanoma — all drugs for Stage IIA Skin Melanoma →

Sponsor

Roswell Park Cancer Institute

Who can join

18 and older, any sex, with Recurrent Melanoma or Stage IA Skin Melanoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants With Successful Intravital Microscopy on Accessible Human Melanoma Tumors During Standard Local Excision Primary · Up to 2 months

A successful intravital microscopic observation will include the ability to identify tumor vessels, measure tumor vessel diameters, determine vessel density per 10 x field and visualize fluorescein within the tumor vessels.

Group	Value	95% CI
Diagnosis (Intravital Microscopy)	70	39.4 – 90.7

"Percentage of Participants With Any Adverse Event Secondary · Up to 5 years

Percentage of participants with any adverse event. Described using upper one-sided 95% Clopper Pearson confidence limits.

Group	Value	95% CI
Diagnosis (Intravital Microscopy)	40	9.6 – 70.4

Blood Flow Rates Secondary · Up to 2 months

Sample tumor characteristics obtained from the intervention will be characterized using descriptive statistics (mean, medians) and 95% confidence intervals.

Group	Value	95% CI
Diagnosis (Intravital Microscopy)	270	206 – 334

Complication Rate Secondary · Up to 5 years

Number of participants with an event that would disrupt the standard surgical procedure or create an adverse event that would not be anticipated from the standard surgery.

Group	Value	95% CI
Diagnosis (Intravital Microscopy)	0

Median Overall Survival Secondary · Up to 5 years

Assessed using Kaplan Meier and Proportional Hazards methods. Collected through routine follow-up processes.

Group	Value	95% CI
Diagnosis (Intravital Microscopy)	NA	13.9 – NA

Median Progression Free Survival Secondary · Up to 5 years

Assessed using Kaplan Meier and Proportional Hazards methods. Collected through routine follow-up processes.

Group	Value	95% CI
Diagnosis (Intravital Microscopy)	NA	13.9 – NA

Percentage of Participants With Treatment Response Secondary · Up to 5 years

Treatment response was based upon the presence of a recurrence of the melanoma at either primary or metastatic sites.

Group	Value	95% CI
Diagnosis (Intravital Microscopy)	0	0 – 31

Adverse events — posted to ClinicalTrials.gov

Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Diagnosis (Intravital Microscopy)

Serious: 1/10 (10%)

Deaths: —

Serious adverse events (1 terms)

Reaction	System	Diagnosis (Intravital Micr…
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	—

Other adverse events (18 terms — click to expand)

Reaction	System	Diagnosis (Intravital Micr…
Anaemia	Blood and lymphatic system disorders	—
Sinus bradycardia	Cardiac disorders	—
Oedema peripheral	General disorders	—
Pyrexia	General disorders	—
Skin infection	Infections and infestations	—
Incision site pain	Injury, poisoning and procedural complications	—
Wound dehiscence	Injury, poisoning and procedural complications	—
Alanine aminotransferase increased	Investigations	—
Aspartate aminotransferase increased	Investigations	—
Blood alkaline phosphatase increased	Investigations	—
Blood magnesium increased	Investigations	—
Blood potassium decreased	Investigations	—
Blood sodium decreased	Investigations	—
Troponin increased	Investigations	—
Hypoalbuminaemia	Metabolism and nutrition disorders	—
Hypocalcaemia	Metabolism and nutrition disorders	—
Joint range of motion decreased	Musculoskeletal and connective tissue disorders	—
Insomnia	Psychiatric disorders	—

Most-reported serious reactions: Pneumonia aspiration.

Data from ClinicalTrials.gov NCT01886235 adverse events section.

Sponsor's own description

This pilot clinical trial studies intravital microscopy for identifying tumor vessels in patients with stage IA-IV melanoma that is being removed by surgery. New imaging procedures, such as intravital microscopy, may determine the extent of melanoma.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Intraoperative intravital microscopy permits the study of human tumour vessels.
   Fisher DT, Muhitch JB, Kim M, Doyen KC, et al · · 2016 · cited 75× · PMID 26883450 · DOI 10.1038/ncomms10684
2. Frontiers in Intravital Multiphoton Microscopy of Cancer.
   Perrin L, Bayarmagnai B, Gligorijevic B. · · 2020 · cited 26× · PMID 32368722 · DOI 10.1002/cnr2.1192
3. A pilot trial of intravital microscopy in the study of the tumor vasculature of patients with peritoneal carcinomatosis.
   Gabriel EM, Kim M, Fisher DT, Mangum C, et al · · 2021 · cited 8× · PMID 33654117 · DOI 10.1038/s41598-021-84430-3