To assess the safety of a single dose of intravenous EC17 injection in patients with ovarian, lung, breast cancer and parathyroid adenomas. To assess concordance of fluorescent signal and tumor status of resected tissue, in the case of ovarian, lung…
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Concordance rate of at least 80% between the pathology results and the
imaging assessment
2. Safety: TEAE* using MedDRA for the administration of EC17 during the study
period (cycle of 14 days), and relevant changes in serum biochemistry, vital
signs, injection site status and general physical examination.
Secondary outcome
1. TBR signal, defined as fluorescent signal of tumor tissue compared to
fluorescence signal of tissue surrounding the tumor.
2. Number and location of FR-a+, cancer+ tumor lesions identified under normal
light only, under both normal light and fluorescent light, and under
fluorescent light only. For breast cancer this will include assessment of tumor
margins.
3. Pharmacokinetics: Cmax, T*, AUC, Tmax, Clearance
Background summary
Intra-operative identification using new real-time imaging modalities that
could provide clear tumor identification and demarcation would provide a useful
tool to reduce positive resection margins hence reducing rates of
re-interventions and increase the identification rate of otherwise occult
malignant lesions. It thereby possibly improves patient outcome and may be used
in staging procedures (ovarian cancer) The use of fluorescent probes that
recognize cancer-specific antigens, in conjunction with a clinical imaging
system permits high sensitivity detection of any desired target within the
surgical field. EC17 is an imaging agent for use in the visualization of FR-a
positive cancer in situ in patients undergoing surgery. Since FR-a is normally
expressed only in the proximal tubules of the kidneys, by activated
macrophages, and in the choroidal plexus, the false positive detection rate is
expected to be low when applied for ovarian-, lung-,breast carcinoma and
parathyroid adenomas.
Study objective
To assess the safety of a single dose of intravenous EC17 injection in patients
with ovarian, lung, breast cancer and parathyroid adenomas.
To assess concordance of fluorescent signal and tumor status of resected
tissue, in the case of ovarian, lung and breast cancer patients.
To assess concordance of fluorescent signal and pathologic status (normal
parathyroid tissue or parathyroid adenoma) of resected tissue in parathyroid
adenoma patients.
To assess the efficacy of EC17 for the intra-operative detection of FR-a
positive ovarian-, lung-, breast cancer and parathyroid adenomas.
Feasibility to detect tumor positive resection margins with intra-operative
fluorescence imaging.
Study design
Phase 1, Open Label, Exploratory Study
Study burden and risks
Burden and risks:
Patients who could become pregnant must agree to use an acceptable form of
birth control from the time of study entry until 30 days after the study.
Possible side effects of the study drug (mild abdominal discomfort, mild
hypersensitivity reactions) or side effects of participation in the study (pain
and black and blue mark after blood drawing, irritation of the skin at i.v.
site)
Extra time investment for the screening and follow-up telephone call
Additional IV for bloodsample collection
Presence of a camera in the operating room
Phototoxicity from the light source
Nonspecificity of localization
Failure to bind to receptors
Fading of the chromophore (photobleaching)
Inability to excite the fluorescent probe or to record emission
Hypersensitivity reactions
Zernikedreef 8
Leiden 2333CL
NL
Zernikedreef 8
Leiden 2333CL
NL
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2013-004089-33-NL |
| CCMO | NL46477.058.13 |