Ovarian CarcinomaPhase 2NCT01689714
Safety and Efficacy of Folatescan (Technetium TC 99M EC20) in Patients With Suspected Ovarian Carcinoma or Recurrent Endometrial Carcinoma
A Phase 2 study testing Tc 99m EC20 in people with Ovarian Carcinoma and Recurrent Endometrial Carcinoma, run by Endocyte.
Trial summary
The folate receptor is overexpressed in many types of cancer, including ovarian and endometrial cancer, and the level of folate receptor expression increases with the stage of the disease. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Carcinoma, Recurrent Endometrial Carcinoma
- What is being tested?
- Tc 99m EC20
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Aug 2003to Aug 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must meet the following eligibility requirements to be enrolled in the study.
- Subject must be 18 years of age or older.
- Subject must have known or strongly suspected ovarian carcinoma or recurrent endometrial carcinoma with at least one identifiable lesion > 1.5 cm as diagnosed by ultrasonography, MRI, or CT.
- Subject must have good kidney function.
- Subject must provide written informed consent prior to enrollment.
Who cannot join
- Subjects must be excluded if any of the following conditions are present:
- Subject is pregnant or breastfeeding.
- Subject is simultaneously participating in another investigational drug study.
- Subject has completed the follow-up phase of any previous study less than 30 days prior to enrollment in this study.
- Subject is unable to tolerate conditions for radionuclide imaging.
- Subject has been administered another radiopharmaceutical that would interfere with the assessment of Technetium Tc 99m EC20.
About this study
Official title: A MULTI-CENTER CLINICAL STUDY TO EVALUATE THE SAFETY AND EFFICACY OF FOLATESCAN (TECHNETIUM Tc 99m EC20) IN PATIENTS WITH SUSPECTED OVARIAN CARCINOMA OR RECURRENT ENDOMETRIAL CARCINOMA
The folate receptor is overexpressed in many types of cancer, including ovarian and endometrial cancer, and the level of folate receptor expression increases with the stage of the disease. Technetium Tc 99m EC20 (99mTc-EC20; FolateScan), a folate-targeted diagnostic radiopharmaceutical, is designed to bind to the folate receptor. Thus, FolateScan may provide an effective method to determine folate receptor-positive (FR+) target tumors, thereby assisting in the identification of those patients who may benefit from folate-targeted therapy.
Read the detailed description
This phase 2, two-center, open-label, single-treatment group, within-patient-controlled study was conducted to:
- Expand the safety database and gather data on the percentage of patients with known or suspected ovarian carcinoma or recurrent endometrial carcinoma who show increased uptake of FolateScan in tumors (primary objective).
- Calculate the sensitivity, specificity, accuracy, positive predictive value, and negative predictive value of FolateScan compared with immunohistochemical (IHC) staining (secondary objective).
- Conditions
- Ovarian Carcinoma, Recurrent Endometrial Carcinoma
- Being tested
- Tc 99m EC20
- Keywords
- Ovarian Carcinoma, Recurrent Endometrial Carcinoma
- Medical subject headings
- Ovarian Neoplasms, Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tc 99m EC20Drug
| Study group | Role | What they receive |
|---|---|---|
| Tc 99m EC20 | Experimental | Patients received 2 intravenous (IV) injections: 1 mg of folic acid (to reduce the uptake of FolateScan in normal tissues), followed 1 to 3 minutes later by 0.1 mg of EC20 labeled with 15 to 25 mCi of technetium-99m (99mTc) over 30 seconds in a total injection volume of 1 to 2 mL.2 Each injection was given as a slow IV push via a free-flowing indwelling IV catheter in an upper extremity vein (i.e., in the antecubital fossa). Receives: Drug: Tc 99m EC20 |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2012 (estimated)
- Study startAug 2003
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endocyte
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Val J Lowe, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01689714
- Sponsor's protocol ID
- EC20.4
- Status last verified
- Sep 2012
- First submitted
- 9 Sep 2012
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A MULTI-CENTER CLINICAL STUDY TO EVALUATE THE SAFETY AND EFFICACY OF FOLATESCAN (TECHNETIUM Tc 99m EC20) IN PATIENTS WITH SUSPECTED OVARIAN CARCINOMA OR RECURRENT ENDOMETRIAL CARCINOMA
- ClinicalTrials.gov ID
- NCT01689714
- Acronym / sponsor ID
- EC20.4
- Conditions
- Ovarian Carcinoma, Recurrent Endometrial Carcinoma
- Keywords
- Ovarian Carcinoma, Recurrent Endometrial Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- EndocyteIndustry (pharma, biotech, devices)
- Study start
- Aug 2003
- Study completion
- Aug 2005 (actual)
- First posted
- 21 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The folate receptor is overexpressed in many types of cancer, including ovarian and endometrial cancer, and the level of folate receptor expression increases with the stage of the disease. Technetium Tc 99m EC20 (99mTc-EC20; FolateScan), a folate-targeted diagnostic radiopharmaceutical, is designed to bind to the folate receptor. Thus, FolateScan may provide an effective method to determine folate receptor-positive (FR+) target tumors, thereby assisting in the identification of those patients who may benefit from folate-targeted therapy.
Detailed description
This phase 2, two-center, open-label, single-treatment group, within-patient-controlled study was conducted to:
- Expand the safety database and gather data on the percentage of patients with known or suspected ovarian carcinoma or recurrent endometrial carcinoma who show increased uptake of FolateScan in tumors (primary objective).
- Calculate the sensitivity, specificity, accuracy, positive predictive value, and negative predictive value of FolateScan compared with immunohistochemical (IHC) staining (secondary objective).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tc 99m EC20 | Experimental | Drug: Tc 99m EC20Patients received 2 intravenous (IV) injections: 1 mg of folic acid (to reduce the uptake of FolateScan in normal tissues), followed 1 to 3 minutes later by 0.1 mg of EC20 labeled with 15 to 25 mCi of technetium-99m (99mTc) over 30 seconds in a total injection volume of 1 to 2 mL.2 Each injection was given as a slow IV push via a free-flowing indwelling IV catheter in an upper extremity vein (i.e., in the antecubital fossa). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects must meet the following eligibility requirements to be enrolled in the study.
Key exclusion criteria (6 listed)
- Subjects must be excluded if any of the following conditions are present:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tc 99m EC20 | Drug | Tc 99m EC20 |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Val J Lowe, MD principal investigator
Mayo Clinic
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tc 99m EC20 in people with Ovarian Carcinoma and Recurrent Endometrial Carcinoma, run by Endocyte.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.