A Phase 1, Open Label, Exploratory Study for the Intra-operative Imaging of Folate Receptor Alpha Positive Ovarian, Lung, Breast Cancer and Parathyroid adenomas using the Tumor Specific Imaging Agent EC17

Phase 2

Completed

• Conditions: mammacarcinoma / breast cancer; parathyroid adenomas; primary non small cell lung carcinoma / lung cancer; primary ovarian carcinoma / ovarian cancer; 10027655

• Registration Number: NL-OMON40272
• Lead Sponsor: Centre for Human Drug Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 75

Inclusion Criteria

General Inclusion Criteria
1. Subjects 18 years of age and older
2. Normal and clinically acceptable medical history, medical physical examination and vital signs at screening
3. Patients are clinically fit for surgery
4. Absence of anaphylactic reactions to EC17 or insects or allergy to fluorescein
5. No pregnancy, excluded by pregnancy test
6. The patients screening ECG and clinical laboratory test results are within normal range or are clinically insignificant
7. Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
8. Before patient registration, written informed consent must be given
9. No impaired renal or liver function. Impaired renal function defined as eGFR<50 and impaired liver function defined as evidenced by greater than 3x the upper limit of normal (ULN) for ALT, AST, or total bilirubin.;Lung Cancer Specific Inclusion Criteria
1. Primary diagnosis of primary NSCLC lung cancer with FR-a positive tumor proven by biopsy planned for surgery
2. No previous thorax surgery, except for mediastinoscopy
3. No previous radiation therapy for lung cancer;Ovarian Cancer Specific Inclusion Criterium
1. Known or high clinical suspicion of primary ovarian cancer planned for either primary debulking surgery , intervaldebulking or staging procedure;Breast cancer specific criterium
1. Primary diagnosis of primary breast cancer with FR-a positive tumor proven by biopsy planned for surgery;Parathyroid adenoma
1. Primary diagnosis of parathyroid adenoma planned for parathyroidectomy

Exclusion Criteria

1. Any condition that in the opinion of the investigators could potentially jeopardize the health status of the patient

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1. Concordance rate of at least 80% between the pathology results and the<br /><br>imaging assessment<br /><br><br /><br>2. Safety: TEAE* using MedDRA for the administration of EC17 during the study<br /><br>period (cycle of 14 days), and relevant changes in serum biochemistry, vital<br /><br>signs, injection site status and general physical examination.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. TBR signal, defined as fluorescent signal of tumor tissue compared to<br /><br>fluorescence signal of tissue surrounding the tumor.<br /><br><br /><br>2. Number and location of FR-a+, cancer+ tumor lesions identified under normal<br /><br>light only, under both normal light and fluorescent light, and under<br /><br>fluorescent light only. For breast cancer this will include assessment of tumor<br /><br>margins.<br /><br><br /><br>3. Pharmacokinetics: Cmax, T*, AUC, Tmax, Clearance</p><br>