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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03246659 |
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Date of registration:
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28/07/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Radiolabelled CCK-2/Gastrin Receptor Analogue for Personalized Theranostic Strategy in Advanced MTC
GRAN-T-MTC |
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Scientific title:
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Phase I Clinical Trial Using a Novel CCK-2/Gastrin Receptor-localizing Radiolabelled Peptide Probe for Personalized Diagnosis and Therapy of Patients With Progressive or Metastatic Medullary Thyroid Carcinoma |
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Date of first enrolment:
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August 2016 |
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Target sample size:
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16 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03246659 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: Single (Participant).
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Phase:
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Phase 1
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Countries of recruitment
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Austria
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Germany
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Netherlands
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Poland
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Slovenia
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Contacts
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Name:
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Paola Anna Erba, Professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Azienda Ospedaliero, Universitaria Pisana |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
Related to the medullary cancer of the thyroid:
1. Histologically documented medullary cancer of the thyroid.
2. Presence of more than one distant or nodal, surgically untreatable metastases
confirmed with either 18F-FDG PET/CT or enhanced-CT or MRI OR
3. Doubling time (DT) of serum calcitonin level less than two years prior to study entry
and negative imaging.
4. Karnofsky performance status > 50%.
5. Life expectancy of more than 6 months.
Related to the patient:
6. Male or female patients aged >18 years without upper age limit.
7. Ability to understand and willingness to sign a written informed consent document.
8. Written informed consent obtained according to international guidelines and local
laws.
Exclusion Criteria:
Related to the MTC:
1. Patients with surgically treatable medullary thyroid cancer.
2. Patients with history of second malignancy other than basal cell carcinoma of the
skin.
Related to previous or concomitant therapies :
3. Participation in any other investigational trial within 3 months of study entry.
4. Previous external beam radiation therapy within two years.
5. Organ allograft requiring immunosuppressive therapy.
Related to the patient:
6. Pregnancy, breast-feeding.
7. Known hypersensitivity to gastrin analogues.
8. Patients with concurrent illnesses that might preclude study completion or interfere
with study results.
9. Patients with bladder outflow obstruction or unmanageable urinary incontinence.
10. Clinical diagnosis of disseminated intravascular coagulation.
11. Serum creatinine >170 µmol/L, GFR < 40 mL/min
12. Known history of hypersensitivity to gelofusine /gelaspan or any other
contraindications to gelofusine/gelaspan infusion
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Medullary Thyroid Carcinoma
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Intervention(s)
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Drug: 111In-CP04 with co-administration of gelofusine/gelaspan
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Drug: 111In-CP04
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Primary Outcome(s)
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Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of CP04
[Time Frame: 4 months]
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Pharmacokinetics of 111In-CP04
[Time Frame: 72 hours from 111In-CP04 injection]
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Uptake of 111In-CP04 in tumor and other tissues
[Time Frame: 72 hours from 111In-CP04 injection]
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Secondary Outcome(s)
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Comparison of pharmacokinetic/imaging effect of low and high peptide amount
[Time Frame: 3 years]
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Gelofusine/gelaspan injection and CP04 kidney uptake
[Time Frame: 3 years]
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Diagnostic sensitivity/specificity of 111In-CP04 to detect cancer lesions
[Time Frame: 3 years]
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Dosimetry
[Time Frame: 72 hours from 111In-CP04 injection]
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Secondary ID(s)
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GRAN-T-MTC
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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