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Topical Fluorescent Nanoparticles Conjugated Somatostatin Analog for Suppression and Bioimaging Breast Cancer

Primary Purpose

Breast Cancer, Skin Cancer, Skin Diseases

Status
Unknown status
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Quantum dots coated with veldoreotide
Topical approved placebo
Sponsored by
Al-Azhar University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

25 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. Women, 25 to 60 years old.
  2. Breast biopsy within 60 days of registration (dosing) without proof of aggressive cancer in any specimen;
  3. 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);
  4. Participants performed traditional regional radical therapy (modified or moderate radical mastectomy) with or without neoadjuvant/adjuvant chemotherapy or radiotherapy;
  5. 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:

  1. Patients have previously received any other treatment or have begun adjuvant therapy.
  2. There are any comorbidities that may increase the level of sex hormones: pituitary adenomas, ovarian cancers, thymic carcinomas, etc.
  3. 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.
  4. Patients have been diagnosed with other test drugs for the next 2 months.
  5. 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.
  6. Patients have a family history of endometrial, reproductive or other gynecological malignancies. Transvaginal testing indicated more severe ovary defects and endometrial thickening.
  7. 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.
  8. 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.
  9. 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.
  10. 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).

Sites / Locations

  • Assiut Clinic
  • Buraidah ClinicRecruiting
  • Faculty of Pharmacy
  • Pharmaceutics dept., Faculty of Pharmacy, Qassim University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Quantum dots nanoparticles group

Topical approved placebo cream

Arm Description

A group of female volunteers infected with breast cancer will receive topical Quantum dots in different dosage forms.

A group of female volunteers infected with breast cancer will receive placebo cream as a negative control.

Outcomes

Primary Outcome Measures

Growth inhibition was measured using the sulforhodamine B-based assay.
QDs-VELD have anticancer activity. This study will be determined by measuring the growth inhibition of anticancer activity for QDs-VELD.
Amount of QDs-VELD fluorescent QDs-VELD in the breast periphery due to the fluorescence of QDs using flow cytometry.
The bioimaging effect for scintigraphy of breast cancer.
Growth inhibition was measured by visual determination of breast cancer cells.
QDs-VELD have anticancer activity. This study will be determined by measuring the growth inhibition of anticancer activity for QDs-VELD.

Secondary Outcome Measures

Stable topical quantum dots coated veldoreotide
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.

Full Information

First Posted
October 7, 2019
Last Updated
October 23, 2019
Sponsor
Al-Azhar University
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1. Study Identification

Unique Protocol Identification Number
NCT04138342
Brief Title
Topical Fluorescent Nanoparticles Conjugated Somatostatin Analog for Suppression and Bioimaging Breast Cancer
Official Title
Fluorescent Nanoparticles Conjugated Long-acting Somatostatin Analog for Potent Suppression and Bioimaging Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 15, 2019 (Actual)
Primary Completion Date
June 14, 2021 (Anticipated)
Study Completion Date
December 13, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Azhar University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Breast cancer is a communal malignant disease between Saudi females, with a popularity of 21.8%. Since binding to somatostatin receptors (SSTR) induces no immunogenicity in vivo, somatostatin analog (veldoreotide) (VELD) may be suitable for delivering anti-cancer drugs to target and bioimaging the cancer cells. This work aimed to deliver CdS/ZnS core-shell type quantum dots with carboxylic acid-functionalized (QDs-COOH) which is bioimaging and anticancer nanoparticles decorated VELD as SSTR agonist with anti-cancer activity in the form of topical cream to be deposited deep in the breast periphery.
Detailed Description
QDs-COOH will be conjugated to the N terminal of phenylalanine of VELD when the reaction proceeded at pH 7. Topical cream will be adapted to deliver the conjugated system for maximum deposition through breast cancer cells using emulsion technology. The formulated nanoparticles and cream will be characterized for size using dynamic light scattering, drug-polymer interaction using FTIR, and morphology using SEM. Cellular uptake, permeability and cell viability study of the successful system of interest will be studied in cell culture models using different breast cell lines. Moreover, the in vivo study will also proceed on rats induced breast cancer. Finally, the nanoparticles loaded in a topical cream will be applied with clinical trial approvement on the human breast cancer for bioimaging and treating breast cancer. This work is to present a novel formulation for treatment and bioimaging of breast cancer which can deliver safely to the patients in a high dose to the affected tumor cells.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Skin Cancer, Skin Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Quantum dots nanoparticles group
Arm Type
Active Comparator
Arm Description
A group of female volunteers infected with breast cancer will receive topical Quantum dots in different dosage forms.
Arm Title
Topical approved placebo cream
Arm Type
Placebo Comparator
Arm Description
A group of female volunteers infected with breast cancer will receive placebo cream as a negative control.
Intervention Type
Drug
Intervention Name(s)
Quantum dots coated with veldoreotide
Other Intervention Name(s)
Topical cream
Intervention Description
The active group will receive Quantum dots coated with veldoreotide in different topical dosage forms as an anti-cancer drug.
Intervention Type
Drug
Intervention Name(s)
Topical approved placebo
Other Intervention Name(s)
Topical placebo gel or cream
Intervention Description
The placebo group will receive topical FDA approved in different dosage forms as a negative control drug.
Primary Outcome Measure Information:
Title
Growth inhibition was measured using the sulforhodamine B-based assay.
Description
QDs-VELD have anticancer activity. This study will be determined by measuring the growth inhibition of anticancer activity for QDs-VELD.
Time Frame
6 months
Title
Amount of QDs-VELD fluorescent QDs-VELD in the breast periphery due to the fluorescence of QDs using flow cytometry.
Description
The bioimaging effect for scintigraphy of breast cancer.
Time Frame
6 months
Title
Growth inhibition was measured by visual determination of breast cancer cells.
Description
QDs-VELD have anticancer activity. This study will be determined by measuring the growth inhibition of anticancer activity for QDs-VELD.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Stable topical quantum dots coated veldoreotide
Description
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.
Time Frame
three months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed AH Abdellatif, PhD
Phone
+966507726856
Ext
14618
Email
a.abdellatif@qu.edu.sa
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed AH Abdellatif, PhD
Phone
+966507726856
Ext
2014
Email
ahmed.a.h.abdellatif@azhar.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed AH Abdellatif, PhD
Organizational Affiliation
Qassim University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assiut Clinic
City
Assiut
ZIP/Postal Code
71526
Country
Egypt
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed AH Abdellatif, PhD
Phone
+966507726856
Email
a.abdellatif@qu.edu.sa
Facility Name
Buraidah Clinic
City
Buraidah
State/Province
Al Qassim
ZIP/Postal Code
51171
Country
Saudi Arabia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed AH Abdellatif, Ph.D.
Phone
+966507726856
Email
a.abdellatif@qu.edu.sa
Facility Name
Faculty of Pharmacy
City
Buraidah
State/Province
Qassim
ZIP/Postal Code
51452
Country
Saudi Arabia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed AH Abdellatif, Ph.D.
Phone
+966507726856
Email
a.abdellatif@qu.edu.sa
Facility Name
Pharmaceutics dept., Faculty of Pharmacy, Qassim University
City
Buraidah
State/Province
Qassim
ZIP/Postal Code
51452
Country
Saudi Arabia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed AH Abdellatif, Ph.D.
Phone
+966507726856
Email
a.abdellatif@qu.edu.sa

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The authors could not decide until now a plan to make individual participant data (IPD) available to other researchers.
Citations:
PubMed Identifier
10602908
Citation
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.
Results Reference
result
PubMed Identifier
16478735
Citation
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.
Results Reference
result

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Topical Fluorescent Nanoparticles Conjugated Somatostatin Analog for Suppression and Bioimaging Breast Cancer

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