EC17 for Intraoperative Imaging in Occult Ovarian Cancer
| Status: | Completed |
|---|---|
| Conditions: | Ovarian Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 6/6/2018 |
| Start Date: | November 2013 |
| End Date: | November 12, 2014 |
A Pilot & Feasibility Study of the Imaging Potential of EC17 in Subjects Undergoing Intraoperative Detection of Occult Ovarian Carcinoma
The overall prevalence of Ovarian Cancer in the United States according to the US SEER
Registry is 182,710 women. Ovarian cancer also has the highest mortality rate of the
gynecological cancers. The overall five-year survival rate is 45% and for Stages III and IV
it is only 20-25%. The majority of these are aged 50 years or older, but a few girls less
than 10 years of age have been diagnosed with ovarian cancer. This risk increases with age
and decreases with numbers of pregnancies.
The prognosis for many carcinomas is dependent on the extent of surgical resection. At
present, the ability to perform a complete resection with negative margins is limited by the
investigator's ability to palpate and visualize the tumor and its borders. In many cases, a
more radical resection than necessary is performed in order to provide assurance that
negative margins are achieved. This approach may also increase complication rates, as well as
short- and long-term morbidity. It is desirable to improve visualization of primary tumors
and occult metastases in real time, during surgery. The use of fluorescent probes that
recognize cancer-specific antigens, in conjunction with a clinical imaging system, is under
investigation.
Ovarian cancer is a prototypic disease for this type of clinical imaging system called
intra-operative imaging. Except in Stage IV, the tumors are confined to the pelvis or abdomen
and typically involve extensions or implants onto pelvic or abdominal organs or membranes.
Tumor debulking surgery is common early in the disease process as many of the tumors can be
identified by appearance or feel in the skilled surgeon's hands. The major problems are that
tumors can be diffuse and numerous, of various sizes, and often not readily visible in the
surgical field.
Over 90-95% of serous ovarian cancers express folate receptor (FR)-alpha, making this
receptor an ideal target for marking most ovarian cancers. Folate is the prototypic agonist
at the FR-alpha with potential uses for imaging and targeted therapeutic
strategies.Chemotherapy does not affect FR-alpha expression in ovarian cancer specimens
examined by immunohistochemistry, so prior treatment is unlikely to affect utility of
FR-alpha agonists as imaging or therapeutic agents.
Registry is 182,710 women. Ovarian cancer also has the highest mortality rate of the
gynecological cancers. The overall five-year survival rate is 45% and for Stages III and IV
it is only 20-25%. The majority of these are aged 50 years or older, but a few girls less
than 10 years of age have been diagnosed with ovarian cancer. This risk increases with age
and decreases with numbers of pregnancies.
The prognosis for many carcinomas is dependent on the extent of surgical resection. At
present, the ability to perform a complete resection with negative margins is limited by the
investigator's ability to palpate and visualize the tumor and its borders. In many cases, a
more radical resection than necessary is performed in order to provide assurance that
negative margins are achieved. This approach may also increase complication rates, as well as
short- and long-term morbidity. It is desirable to improve visualization of primary tumors
and occult metastases in real time, during surgery. The use of fluorescent probes that
recognize cancer-specific antigens, in conjunction with a clinical imaging system, is under
investigation.
Ovarian cancer is a prototypic disease for this type of clinical imaging system called
intra-operative imaging. Except in Stage IV, the tumors are confined to the pelvis or abdomen
and typically involve extensions or implants onto pelvic or abdominal organs or membranes.
Tumor debulking surgery is common early in the disease process as many of the tumors can be
identified by appearance or feel in the skilled surgeon's hands. The major problems are that
tumors can be diffuse and numerous, of various sizes, and often not readily visible in the
surgical field.
Over 90-95% of serous ovarian cancers express folate receptor (FR)-alpha, making this
receptor an ideal target for marking most ovarian cancers. Folate is the prototypic agonist
at the FR-alpha with potential uses for imaging and targeted therapeutic
strategies.Chemotherapy does not affect FR-alpha expression in ovarian cancer specimens
examined by immunohistochemistry, so prior treatment is unlikely to affect utility of
FR-alpha agonists as imaging or therapeutic agents.
Inclusion Criteria:
1. Female subjects 18 years of age and older
2. Female subjects of childbearing potential or less than 2 years postmenopausal agree to
receive a urinary or serum beta HCG test prior to subject enrollment. Documentation
must be acquired for women of menopausal or post-menopausal status prior to subject
enrollment if they are below the age of sixty (60).
3. Primary diagnosis, or at high clinical suspicion, of primary ovarian cancer:
1. Patient is scheduled to undergo laparotomy OR
2. Patient is scheduled to undergo laparoscopy then pre-authorized laparotomy if
cancer is found.
Exclusion Criteria:
1. Known sarcomatous histologies
1. Recurrent ovarian cancer
2. Known FR-alpha negative cancer
3. Planned surgical approach via laparoscopy or robotic (no intention to perform
laparotomy)
4. History of anaphylactic reactions to Folate-FITC (EC17) or insects
5. Pregnancy
6. Brain metastases
7. Taking compounds that inhibit active transport of organic anions (probenecid)
8. Hepatic impairment, as evidenced by greater than 3x the upper limit of normal (ULN)
for ALT, AST, or total bilirubin (except for known cases of Gilbert's syndrome), or
renal impairment, as evidenced by greater than 1.5x the ULN for BUN or creatinine
9. Received study agent in another investigational drug or vaccine trial prior to surgery
10. At-risk patient populations
1. People who would easily be lost to follow up (ex: People who are homeless or
alcohol dependent)
2. Patients unable to participate in the consent process (children and neonates)
We found this trial at
1
site
3400 Spruce St
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
(215) 662-4000
Principal Investigator: Sunil Singhal, M.D.
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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