Topical Fluorescent Nanoparticles Conjugated Somatostatin Analog for Suppression and Bioimaging Breast Cancer
Fluorescent Nanoparticles Conjugated Long-acting Somatostatin Analog for Potent Suppression and Bioimaging Breast Cancer
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Anticipated)
Enrollment
Phase
Phase
- Phase 1
Contacts and Locations
Study Contact
Study Contact
- Name: Ahmed AH Abdellatif, PhD
- Phone Number: 14618 +966507726856
- Email: a.abdellatif@qu.edu.sa
Study Contact Backup
- Name: Ahmed AH Abdellatif, PhD
- Phone Number: 2014 +966507726856
- Email: ahmed.a.h.abdellatif@azhar.edu.eg
Study Locations
-
-
-
Assiut, Egypt, 71526
- Not yet recruiting
- Assiut Clinic
-
Contact:
- Ahmed AH Abdellatif, PhD
- Phone Number: +966507726856
- Email: a.abdellatif@qu.edu.sa
-
-
-
-
Al Qassim
-
Buraidah, Al Qassim, Saudi Arabia, 51171
- Recruiting
- Buraidah Clinic
-
-
Qassim
-
Buraidah, Qassim, Saudi Arabia, 51452
- Not yet recruiting
- Faculty of pharmacy
-
Buraidah, Qassim, Saudi Arabia, 51452
- Not yet recruiting
- Pharmaceutics dept., Faculty of Pharmacy, Qassim University
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Women, 25 to 60 years old.
- Breast biopsy within 60 days of registration (dosing) without proof of aggressive cancer in any specimen;
- Invasive breast cancer verified by histology of ER ≥ 10% (all test results should be checked and validated by the Pathology Department of the involved institution);
- Participants performed traditional regional radical therapy (modified or moderate radical mastectomy) with or without neoadjuvant/adjuvant chemotherapy or radiotherapy;
- Hemoglobin ≥ 90 g / L, neutrophils ≥ 1.5 × 109/L, platelets ≥ 75 × 109/L, AST and ALT ≤ 2.5 times the upper limit for natural (ULN), creatinine serum and urea nitrogen ≤ ULN.
Exclusion Criteria:
- Patients have previously received any other treatment or have begun adjuvant therapy.
- There are any comorbidities that may increase the level of sex hormones: pituitary adenomas, ovarian cancers, thymic carcinomas, etc.
- There are any comorbidities that may decrease sex hormone rates such as hyperthyroidism, hypothyroidism, cirrhosis, extreme obesity, Turner syndrome, lack of sex hormone synthetase, intracranial tumors, pituitary atrophy, etc. Patients have undergone and expected suppression of ovariectomy and ovarian activity.
- Patients have been diagnosed with other test drugs for the next 2 months.
- People of child-bearing age who are not willing to take effective contraception through therapy. Serious non-maligned tumor comorbidities can impair long-term follow-up.
- Patients have a family history of endometrial, reproductive or other gynecological malignancies. Transvaginal testing indicated more severe ovary defects and endometrial thickening.
- Patients had thrombotic incidents such as a cerebrovascular injury (including a transient ischemic attack), deep venous thrombosis, and pulmonary embolism within 6 months of the start of the research.
- Serious insufficiency of the liver with Child-Pugh C class. Serious heart disease of New York Heart Association (NYHA) class ≥III. Patients are considered to be severely allergic to medications.
- Patients have a record of other malignancies over the last five years, with the exception of cutaneous basal cell carcinoma and cervical in situ carcinoma that has been healed. In other instances, investigators do not feel the topics are acceptable for study participants.
- Pregnant or lactating women (women of childbearing age should receive a negative pregnancy test within 14 days of the first dosage or, if pregnant, clinicians are required to undergo an ultrasound review to exclude childbirth).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
ACTIVE_COMPARATOR: Quantum dots nanoparticles group
A group of female volunteers infected with breast cancer will receive topical Quantum dots in different dosage forms.
|
The active group will receive Quantum dots coated with veldoreotide in different topical dosage forms as an anti-cancer drug.
Other Names:
|
|
PLACEBO_COMPARATOR: Topical approved placebo cream
A group of female volunteers infected with breast cancer will receive placebo cream as a negative control.
|
The placebo group will receive topical FDA approved in different dosage forms as a negative control drug.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Growth inhibition was measured using the sulforhodamine B-based assay.
Time Frame: 6 months
|
QDs-VELD have anticancer activity.
This study will be determined by measuring the growth inhibition of anticancer activity for QDs-VELD.
|
6 months
|
|
Amount of QDs-VELD fluorescent QDs-VELD in the breast periphery due to the fluorescence of QDs using flow cytometry.
Time Frame: 6 months
|
The bioimaging effect for scintigraphy of breast cancer.
|
6 months
|
|
Growth inhibition was measured by visual determination of breast cancer cells.
Time Frame: 6 months
|
QDs-VELD have anticancer activity.
This study will be determined by measuring the growth inhibition of anticancer activity for QDs-VELD.
|
6 months
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Stable topical quantum dots coated veldoreotide
Time Frame: three months
|
Stability test will be studied for dosage forms.
The test will carried out by standing the products on shelf life for three months.
The stability test will be recorded using high performance liquid chromatography each thee days.
|
three months
|
Collaborators and Investigators
Sponsor
Sponsor
Publications and helpful links
General Publications
- Clive S, Gardiner J, Leonard RC. Miltefosine as a topical treatment for cutaneous metastases in breast carcinoma. Cancer Chemother Pharmacol. 1999;44 Suppl:S29-30. doi: 10.1007/s002800051114.
- Doroshow JH. Redox modulation of chemotherapy-induced tumor cell killing and normal tissue toxicity. J Natl Cancer Inst. 2006 Feb 15;98(4):223-5. doi: 10.1093/jnci/djj065. No abstract available.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Study Start
Primary Completion (ANTICIPATED)
Primary Completion
Study Completion (ANTICIPATED)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (ACTUAL)
First Posted
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- Qassim QDs-VELD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Skin Diseases
-
NCT07640373Not yet recruitingSkin Condition | Skin Disease | Skin Disorder | Inflammatory Skin Conditions | Autoimmune Skin Diseases | Cancerous Skin Conditions | Genetic Skin Conditions
-
NCT07622160Active, not recruitingSkin Condition | Skin Hydration | Anti Skin Aging
-
NCT07213154RecruitingMalignant Skin Neoplasm | Skin Disorder | Skin Neoplasm
-
NCT06886061Completed
-
NCT04237818Completed
-
NCT03487965Completed
Clinical Trials on Quantum dots coated with veldoreotide
-
NCT04390490Not yet recruitingAcute Myocardial Infarction
-
NCT02308800WithdrawnFoot Ulcer, Diabetic
-
NCT01266096Active, not recruitingNewly Diagnosed or Recurrent Metastatic Melanoma Patients | Malignant Brain Tumors
-
NCT03577600WithdrawnPediatric Brain Tumor
-
NCT02121223UnknownAcute Myocardial Infarction
-
NCT07406308Not yet recruiting
-
NCT02578784UnknownRenal Insufficiency
-
NCT04773145Unknown
-
NCT07563894Recruiting
-
NCT03763214UnknownBile Duct Cancer | Pancreas Cancer | Bile Duct Stricture